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