PERFUSION REPORTS

REPORT
034
DATE
TITLE
Possible Medtronic Fusion Oxygenator Failure
DETAILS OF INCIDENT

60 year old 80 kg male patient. Blood group B+ve. Previous PCI During coronary artery bypass grafting surgery, once Cardiopulmonary bypass (CPB) commenced, there were very high pre-oxygenator P1 line pressures in the bypass circuit (450mmHg). The oxygenator was a Medtronic Fusion. P2 post-oxygenator pressures were within 'normal' range. All potential causes were eliminated but it persised.

The high P1 pressures were not resolving and the p02 oxygen measurement started to fall gradually, although not compromising patient oxygenation. Clotting levels were within range and no clots were seen in the oxygenator. The surgeon was kept informed and the situation monitored before progressing with operation. The decision was made to change out the oxygenator. The anaesthetist was informed and the patient was ventilated conventionally.

CPB was stopped and the oxygenator changed. CPB recommenced and the same high P1 pressures seen again but with no compromise to oxygenation so bypass was continued and monitored very closely. After 30 minutes, the pressures fell to 'normal' levels and remained that way for remainder of the bypass. It was also noted that patient haematocrit on CPB was high (38%) and following discussion with the anaesthetist the patient was diluted with the addition of crystalloid.

Post CPB and protamine, a distal vein graft needed repair and heparin was administered and CPB recommenced. P1 and P2 were both within 'normal levels'. As high P1 pressures seen with both devices on initial use, this was suggestive of a patient specific incident. No untoward effects were noted in the post-op period.

DETAILS OF INJURY TO PATIENT

N/A

TYPE OF DEVICE/MANUFACTURER

N/A

ACTION TAKEN

First oxygenator returned to Medtronic for evaluation. No fault was found with the oxygenator.

In-house discussion:

Following the incident there was a feeling that perhaps the oxygenator was changed out too soon and high pre oxygenator pressures would have stabilised.


RESPONSE FROM MANUFACTURER

N/A

ADDTIONAL INFORMATION

N/A

SUPPORTING VISUALS/VIDEO

N/A

SUPPORTING DOCUMENT

OTHER PERFUSION
 REPORTS

London Core Review Cardiothoracic Surgery Course - Touch icon
London Core Review Cardiothoracic Surgery Course - Help Guide
Select and scroll to view chosen report
REPORT NO
089
1/9/21
Sechrist Gas Blender Sweep on ECMO
REPORT NO
088
1/9/21
Oxygenator High Pressure Events
REPORT NO
087
1/10/21
Leaking one way valve
REPORT NO
086
1/7/21
Electronic Gas Blender Fault
REPORT NO
085
1/2/21
Protamine Administration Issue
REPORT NO
084
1/6/21
Damaged roller pump lid
REPORT NO
083
1/6/21
IABP malfunction
REPORT NO
082
1/1/21
Accidental cardioplegia administration
REPORT NO
081
1/4/21
S5 Double Roller Pump incident
REPORT NO
080
1/5/21
Human factors issue
REPORT NO
079
1/6/21
Centrimag battery module failure
REPORT NO
078
1/6/21
Sampling manifold valve fault
REPORT NO
077
1/5/21
IABP transport issue
REPORT NO
076
1/4/21
Modified Ultrafiltration (MUF) Issue
REPORT NO
075
1/3/21
Electromagnetic interference with HLM
REPORT NO
074
1/2/21
HCU40 Failure
REPORT NO
073
1/2/21
HCU40 valve failures
REPORT NO
072
1/1/21
HCU40 failure
REPORT NO
071
1/1/21
LIVA NOVA STATEMENT ON CENTRIFUGAL HEAD
REPORT NO
070
1/1/21
Loose component on circuit
REPORT NO
069
1/12/20
Centrifugal Head noise
REPORT NO
068
1/11/20
Venous Reservoir disposable issue
REPORT NO
067
1/11/20
Failure of Heater Cooler due to leaking valves
REPORT NO
066
1/11/20
Failure of Valves on heater cooler unit
REPORT NO
065
1/9/20
Intra Aortic Balloon Pump (IABP) Failure
REPORT NO
064
1/9/20
Centrifugal head failure
REPORT NO
063
1/8/20
Centrifugal head issue 4
REPORT NO
062
1/8/20
Human Factors Issue
REPORT NO
061
1/8/20
LIVA NOVA RESPONSE TO REPORTED CENTRIFUGAL HEAD ISSUE
REPORT NO
060
1/8/20
Oxygenator Fibre Leak
Perfusion Report cards are shown in batches of 30 at any one time where available.
120
119
118
117
116
115
114
112
111
110
109
108
107
106
105
104
103
102
101
100
099
098
097
096
095
094
093
092
091
090
089
088
087
086
085
084
083
082
081
080
079
078
077
076
075
074
073
072
071
070
069
068
067
066
065
064
063
062
061
060
059
058
057
056
055
054
053
052
051
050
049
048
047
046
045
044
043
042
041
040
039
038
037
036
035
034
033
032
031
030
029
028
027
026
025
024
023
022
021
020
London Core Review Cardiothoracic Surgery Course - Touch icon
London Core Review Cardiothoracic Surgery Course - Help Guide
Know the report number? Scroll horizontally through the circle icons and select to view the appropriate report.