PERFUSION REPORTS

REPORT
043
DATE
1/7/2019
TITLE
Getinge Mal-Position Of IABP Catheter
DETAILS OF INCIDENT

A mal-positioned Intra-Aortic Balloon catheter was punctured by the surgeon's blade when preparing for aortic cannulation and cardiopulmonary bypass. The puncture hole in the catheter was of 5-8mm in length and allowed the full Helium contents of the balloon itself to be purged into the ascending aorta of the patient.

DETAILS OF INJURY TO PATIENT

On reducing sedation on Intensive Care, the patient developed a seizure. A CT of the head revealed extensive cerebral infarcts consistent with helium embolization. Unfortunately, the patient did not recover neurologically and sadly passed away six days post-op.

TYPE OF DEVICE/MANUFACTURER

Maquet/Getinge

Size And Type: 7.5 Linear

ACTION TAKEN

Review of all Trust IAB Policies with a particular focus on insertion and removal guidelines; Review of Gas Embolism guidelines to ensure they are current; formalise IAB training across surgical team; perform MDT scenario training; Getinge have interrogated their own product complaints/reports and determined that the relevant Lot Numbered product was not involved any similar reports.

MHRA - Informed

NPSA - informed

Local Risk Group - Informed

RESPONSE FROM MANUFACTURER
ADDTIONAL INFORMATION
SUPPORTING VISUALS/VIDEO
SUPPORTING DOCUMENT

OTHER PERFUSION
 REPORTS

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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
REPORT NO
059
1/5/20
Failure to remove CO2 effectively
REPORT NO
058
1/7/20
Centrifugal Head Issue 3
REPORT NO
057
1/6/20
Centrifugal Head Issue 2
REPORT NO
056
1/1/20
Centrifugal Head Issue
REPORT NO
055
1/2/20
Faulty Pressure Relief Valves
REPORT NO
054
1/4/20
Leaking ALF
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