Safety Advisory SA 2017/03
The Safety Committee and Executive Committee would like to make the membership aware of the recent update from Public Health England (PHE).
https://www.gov.uk/government/publications/infections-associated- with-heater- cooler-units-used-in- cardiopulmonary-bypass-and-ecmo
We continue to recommend that units work within the guidance provided by PHE, specific Manufacturers Guidelines and with reference to the Infection Control and Health and Safety Departments within your hospital.
Should you or your department wish to discuss this issue further or have any queries, the safety committee (
) are willing to be of assistance, but we would also like to remind you that the most up to date information will always be held by PHE.
Safety Advisory: SA 2015/09
The joint Perfusion bodies and their Safety Committee (SC) are fully aware of the recent circumstances and situation surrounding the potential Mycobacterial contamination of heater/cooler units and the possible but unconfirmed link to endocarditis and other surgical site infections.
We are working closely with the relevant organisations involved in this investigative process including Public Health England (PHE), NHS England, MHRA, DH, SCTS and ACTA. PHE is coordinating the national response. PHE are currently looking at de-escalating the issue with a timeline consistent according to the final round of testing on some of the latest devices. By de-escalation, PHE are referring to some final guidance that will be available to all parties concerned that should be used by departments to develop a strategy plan.
We recommend that all departments familiarise themselves will all the current guidance available via the links to the documents below and that you liaise closely with your local infection control team on this matter.
Should you or your department wish to discuss this issue further or have any queries concerning these documents, the safety committee (
) are willing to be of assistance, but we also need to remind you that the most up to date information will always be held by PHE.
MHRA alert, https://assets.digital.cabinet-office.gov.uk/media/557958c640f0b615b8000025/MDA-2015-022_Heater-coolers.pdf
PHE documentation, https://www.gov.uk/government/collections/mycobacterial-infections-associated-with-heater-cooler-units
Safety Advisory: SA 2014/02We have been advised by the MHRA that Swissmedic, the Swiss Agency for Therapeutic Products has recently published a safety notice written by the Federal Office of Public Health (FOPH) in Switzerland concerning a rare number of cases of a water borne infection in cardiac surgery patients that have had implants. The effects of such a bacterial infection can take one or two years to develop in some cases.They have had 6 known cases between 2008 and 2012.
With regards to the cause of these infections the FOPH report states:
"The cause of the infection is suspected to be the contamination of a technical device (heater cooler unit) that is used in hospitals during open heart surgery to control the temperature of the blood. These devices are operated with filtered tap water. The bacterium was detected in the water and in the discharged air of the devices in several Swiss hospitals. It is possible that during very few of these operations, a transmission of the bacterium occurred. However, the exact route of transmission has not yet been established."
Whilst it is not conclusive that the heat-cooler is the cause of these infections the Safety Committee felt it helpful to remind the membership of the importance of following the manufacturers guidelines on disinfecting and cleaning their heater-coolers and ensuring the departmental protocols include these practices.
Attached is the link to the full Swissmedic report along with the Sorin guidelines for the disinfecting and cleaning their heater-coolers.
Safety Notice: SN 2014/01
Maquet Cardiovascular have issued a Safety Notice concerning the temperature reading on a certain number of PLEGIOX Cardioplegia heat exchangers. The problem is limited to selected lot numbers and only affects a small number of hospitals in the UK. The cause of the problem is a change to a moulded component, which restricts the depth the external temperature probe can be inserted into the device. There could be up to a three degree Celsius difference in read and actual temperature however the performance of the heat exchanger is unaffected.
The Safety Committee would like to make the UK community aware of this situation, which is being dealt with by the Maquet Technical Services team. Further information and affected lot numbers can be found in the following documents Plegiox Field Safety Notice.pdf and Plegiox Lot Numbers.pdf, which can be accessed below:
Safety Report: SR 2013/02
A patient with complex medical history (IDDM and leg amputation 20 years previous) underwent CABG surgery. The pre-operative TEG showed a relative hypercoagulable state.
Surgery proved complex and protracted due to poor targets and diffuse disease. Three episodes of cardiopulmonary bypass (CPB) were necessary due to cardiovascular instability.
CPB run 1 was long but uneventful and was successfully terminated. Protamine was administered along with platelets and FFP. The CPB circuit was flushed with 1000ml Hartmann’s solution. Patient instability led to re-instatement of CPB prior to which heparin was administered to the patient and a correct therapeutic ACT was obtained. 15KIU heparin was added to the pump prime and re-circulated.
CPB run 2, from the onset presented a failing oxygenator (low pO2 and low saturations) despite 100% oxygen. The device was changed out successfully. An extensive report from the manufacturer identified fibrin build up and no fault with the device. Due to suspected heart failure, an IABP was inserted directly into the aorta (no femoral access possible) to assist weaning from CPB run 2. Low flow was used for approximately 58 minutes to assist with IABP insertion and timing. CPB was eventually terminated but cannulae were left in situ for 52 min.
CPB run 3 commenced due to continued instability. The perfusionist was unable to achieve full flow and a hissing noise was heard. The arterial line filter was seen to have clotted off. CPB was terminated and the patient passed away. Clots were seen in the arterial line and the aortic cannula.
An extensive report from the manufacturer identified fibrin build up within the first oxygenator and no fault with the device. The second oxygenator and circuit were not kept for investigation. As part of a tender process, the oxygenators in use for this case were new to the department.
A Comprehensive Investigation Report from the institution revealed that it has not been possible to conclusively identify contributory factors that led to the patient’s death. There was no inquest. Two possible explanations in that report were:
• Possible unidentified patient coagulopathy (? Antiphospholipid syndrome)
• New oxygenator device in use during surgery
Is it important to note that neither explanation can be fully established or eliminated.
All standard protocol was followed during the procedure and all ACT results were well above the necessary threshold throughout the case. Inadvertent protamine administration was ruled out.
This incident has led a focus on awareness in the following areas:
• A hypercoagulable disorder may play a role in oxygenator failure. Any indication of such a state may call for improved point of care testing. Anti-Phospholipid Syndrome which occurs in 2% of the population. Antibodies present in patients with Antiphospholipid syndrome (APLS) are reported to affect a kaolin ACT. These antibodies attack some fats and proteins in the blood causing it to clot. Blood becomes stickier increasing the risk of blood clots. In a patient with known APLS, a celite ACT is recommended with a higher target value and plotting of heparin/ACT titration curves pre-operatively to determine patient-specific target ACT values. Heparin concentrations >3u/ml should be considered. Use of the HepCon system would prove valuable. Antifibrinolytic agents are not recommended.
• When evaluating any new equipment, the whole surgical team should be made aware at the team briefing.
• Any incidents, where faulty devices have been proved, should be reported to the MHRA as a precaution.
• Any device or disposable with suspected fault should be retained for investigation along with all serial
and lot numbers.
• Consideration should be given to recirculation of the blood remaining in the pump during any significant period where CPB has been terminated but where the cannula may remain in situ. This will prevent the blood from stagnating. Consider taking a sample for ACT analysis and regularly flushing the cannulae.
• During low flow CPB (used here for the assistance of IABP therapy), ensure that the minimum flow rate for the oxygenator in use is achieved or exceeded. This minimum flow rate will be quoted in the manufacturers Instructions for Use and should be incorporated into the departmental protocols.
Safety Report: SR 2013/01
On establishing cardiopulmonary bypass the surgical team became aware that air had entered the heart after noting the presence of an air bubble within the cardioplegia cannula. The visible air was cleared at the time and the operation continued.
Post-operatively, it became evident that the Patient had sustained a hypoxic brain injury. The cause was identified as a significant air embolism during the institution of bypass. It was later established that the LV vent had been configured such that it temporarily blew air into the left ventricle.
The patient did not regain consciousness post-operatively. Following repeated CT scanning and clinical reviews, the prognosis was felt to be extremely poor. Treatment was withdrawn and the patient died.
The root causes were human error and equipment factors. Human factors were also contributory.
• The equipment was checked and found to be functioning normally. Due to the design of the pumps, the risk of human error leading to an inadvertent change of flow direction to the vent pipe was real. This potential to inadvertently reverse the flow on the Sorin S3 pump has been demonstrated to all members of the perfusion team. This has increased vigilance and patient safety.
• Once the heart-lung machine has been set-up and existing safety checks completed, it should be switched to zero revolutions rather than placed in standby mode. This should be added to the Perfusionists protocol checklist.
• Fluid should be aspirated into the vent line prior to its insertion (wet table test). This is a task that should be incorporated into the normal checks undertaken by the scrub nurse.
• Human factors were contributory to this incident. Investigating this incident has provided a further platform for improving communication and team working within the shared leadership environment of the operating theatre.
• Massive Air Embolism protocol review.
• Introduction of 1 way valves to the vent suction line.
The safety committee recognises the potential for human error and recommends all users of the S3 pump to raise awareness of the potential to inadvertently reverse the flow on these pumps. The wet table test of all suckers should be standard to avoid errors. Wet testing of vents prior to insertion will further increase the safety of these devices. The introduction of one way valves to the vent lines should be considered. Communication within the theatre team should always be a priority and without barriers.
Safety Report: SR 2012/03
During a routine valve procedure the operating surgeon placed a transeptal vent into the Left Ventricle (LV). When the vent pump was turned on it was noticed that the LV did not empty and air bubbles were seen in the left coronary arterial tree and a significant amount of air appeared to be in the LV on Transoesophageal Echo.
The problem was that the sucker used to vent the heart was not sucking. Another sucker was used and this rectified the problem. The LV emptied and the procedure continued. The patient suffered some neurological deficit that slowly resolved that was put down to this air embolus. It was felt that the sucker failure was due to the tubing in the raceway of that sucker being placed in the wrong direction.
There are a number of issues here, direction of pump rotation, orientation of tubing in the pump raceway and adequate testing of suckers. The most effective method of preventing this error is the wet table test with the scrub nurse. We urge all units to adopt this final check for all suckers.
This error has appeared on this site recently and demonstrates again the value and importance of checking the suckers and vents actually suck and this can best be checked by dipping the tubing into a jug of fluid on the table. The Safety Committee would again like to encourage the appropriate use of checklists at all stages of the operation to ensure we deliver the safest possible bypass to our patients.
Safety Advisory: SV 2012/02
It has recently come to the attention of the Safety Committee of a potential issue regarding two different drug ampoules that look very similar. The drugs in question are Heparin and St. Thomas’s Cardioplegia. The Safety Committee would strongly recommend the use of double-checking for all drugs that are used by the Perfusionist. If you have experience of this or different drug ampoules causing potential confusion please use the Web Reporting form on this site to let us know.
Safety Notice: SN 2012/01Problem
Maquet Cardiovascular have issued a Safety Notice concerning the blood outlet connector on a range of their oxygenators. In very rare situations, the adhesive bonding the outlet connector fails and the connector can fall off.
The Safety Committee would like to make the UK community aware of this situation which is being dealt with by the Maquet Technical Services team. Further information can be found in the following document Field Safety Notice.pdf which can be accessed below:
Safety Notice: SN 2011/08Problem
The Sorin Group Italia have issued a Field Safety Corrective Action Notice concerning a number of complaints recieved from its customers regarding a leak between the blood and water compartments of the heat exchanger in a number of its oxygenators. The reported occurrence rate is very low, < 0.002%. Investigations suggest that the leaks may be caused by prolonged contact with sodium chloride (NaCl), causing micro holes to appear in the heat exchanger.
The Safety Committee would like to make the UK community aware of this situation and suggest that the instructions be followed in the attached document.
Safety Report: SR 2011/07
At the end of a routine cardiac surgical procedure, Cardiopulmonary Bypass (CPB) was terminated, however, it was not noticed at this time there was still a clamp fully occluding the aorta. Once this was realised and removed and despite the best efforts of the team the patient sadly passed away.
The patients' safety is paramount and if there is any doubt about patient blood pressure monitoring the safest course of action is to return to CPB. No measured parameters should be disregarded without concrete evidence to the contrary or without consulting the multi-disciplinary team. At key events during any procedure such as application or removal of clamps there should be a check and cross-check communication verification between team members. Standard Operating Procedures for the various phases of CPB should be implemented and if necessary specific checklists should be used.
Safety Notice: SN 2011/06
Maquet Cardiovascular have issued a Safety Notice concerning two issues with their hardware. The first is transient increases in pump speeds on twin pump modules and the second is in regards to the possible ingress of liquids around the PSB cover. This relates to HL20 four and five pump bases with twin pump modules manufactured before 2011.
The Safety Committee would like to make the UK community aware of this situation which is being dealt with by the Maquet Technical Services team. Further information can be found in the following document FSN1.pdf which can be accessed below:
Safety Notice: SN 2011/05
Terumo Cardiovascular Systems has entered into a consent decree agreement with the US Food and Drug Administration (FDA) to address concerns the FDA have with the deficiencies in the Quality Systems at the Terumo CVS manufacturing facility in Ann Arbor, USA.
The Safety Committee recognises that there are no safety related issues at this time but we want to make the UK community aware of this situation. We will continue to monitor events and report further developments as necessary. Current users of Terumo products, produced at the Ann Arbor plant, will have already signed the relevant paperwork to continue using those products. Further information can be found at www.terumo-cvs.com/consentdecree/
Safety Advisory: SV 2011/04
With the increasing use of bio-glues, the Safety Committee would like to remind you of the importance of turning all suckers off before the bio-glue is used.
Safety Alert: SA 2011/03
Terumo have recently issued a field safety notice alerting all CDI500 users to the possibility of parameter drift during a case and suggest that users do not administeror withold treatment based soley on the CDI values.
The Safety Committee recommends that users be aware that this a trend monitoring device and the CDI prarmeters are checked with a blood-gas machine if there is any cause for concern.
Safety Report: SR 2011/02
During a complex redo operation, cardiopulmonary bypass (CPB) was instituted with an additional, peripheral venous line placed in the superior vena cava (SVC). At the end of CPB there was only a single clamp applied to the venous line between the SVC and the venous reservoir. When this clamp was removed the patient exsanguinated and due to distractions, this was not recognised. The patient subsequently died.
The Safety Committee recommends that systems need to be in place so that the entire multidisciplinary theatre team are aware of the positioning and visibility of every clamp and every line. This awareness needs to explicit and documented. A protocol-based system should be developed to ensure that there is verbal acknowledgement by each member of the team when each clamp is applied and removed, and when each line is inserted and removed. This verbal communication should be supplemented by preoperative team briefings that include a discussion of the operative strategy regarding conduct of bypass and a visual record of this strategy should be displayed in theatre (possibly on a whiteboard). These protocols and discussions need to address all aspects of the conduct of bypass, relevant to this specific case they must include the strategy of weaning and de-cannulation.
Safety Alert: SA 2011/01
A recent publication in the media has thrown serious doubt on research carried our by Prof J. Boldt in Germany into the use of HES and colloids in the manangement of patients and this includes their use in cardiac surgery.
The Safety Committee feels it important to highlight this information and recommends that Perfusion and Hospital policies on the use of these fluids be reviewed dependant upon the outcome of an MHRA investigation. The AAGBI (www.aagbi.org.uk <http://www.aagbi.org.uk/ > ) have published on their website that "there is no new evidence that starches are not safe". We also suggest you monitor the situation with your local Anaesthetic and Surgical colleagues.
Safety Report: SR 2010/02
Whilst using a mechanical gas blender the first gas on cardiopulmonary bypass showed a very low pCO2. Reducing gas flow rates made no difference. Swapping out the blender resolved the problem. On inspection the fine trim rotameter knob was found to be fully open delivering a gas flow in excess of 30L/min. When fully open the small ball float is difficult to visualise.
The Safety Committee recommends that a check is made on the gas blender to ensure that the rotameter knobs are correctly set prior to establishing CPB. Consider incorporating into departmental checklists if not already included.
Safety Report: SR 2010/01
After instigating cardiopulmonary bypass for an urgent procedure, it was noticed the venous return was not satisfactory to sustain full flow despite surgical manipulation. CPB was discontinued, the venous line disconnected at the inlet of the venous reservoir where a non-hospital standard luer cap was found lodged inside the venous inlet port. This was removed, CPB re-instituted and no further problems were encountered. No harm came to the patient.
The Safety Committee recommends that a thorough inspection of all blood path ports be made during circuit assembly and suitable flow and pressure checks be performed prior to establishing CPB. Consider incorporating into departmental checklists if not already included.
Safety Report: SR 2009/02
The securing harnesses that are supplied with the CS300 were not designed for the CS300 device and therefore do not adequately secure the machine during ambulance transport.
The Safety Committee in conjunction with Maquet (Datascope) recommend that the harnesses be returned to Maquet and if ambulance transport of a CS300 is required alternative securing arrangements should be arranged.
The full MHRA alert can be viewed by clicking button below
Safety Report: SR 2009/01
Following a recent safety incident where, due to a heat exchanger fault, a water to blood leak occurred in an oxygenator:
The Safety Committee would like to re-affirm that water-side leak are checked for before the oxygenator is primed for cardiopulmonary bypass and that the manufacturers¹ instructions for use (IFU) are followed when
setting up and priming an oxygenator.
The Safety Committee also recommends that departmental protocols clearly state the above.
Further information can be found here