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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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
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REPORT NO
054
1/4/20
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REPORT NO
053
1/2/20
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REPORT NO
052
1/3/19
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REPORT NO
051
1/12/19
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REPORT NO
050
1/10/19
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REPORT NO
049
1/12/19
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REPORT NO
048
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REPORT NO
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REPORT NO
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REPORT NO
045
20/11/19
Tubing Detachments
REPORT NO
044
27/11/19
Interruption to IABP counterpulsation
REPORT NO
043
1/7/19
Getinge Mal-Position Of IABP Catheter
REPORT NO
042
1/2/19
Avalon Dual Lumen Cannula Crack
REPORT NO
041
1/2/19
Custodial Rubber Fragmentation In Spiked Bag
REPORT NO
040
1/10/18
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REPORT NO
039
1/10/18
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REPORT NO
038
1/10/18
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REPORT NO
037
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REPORT NO
036
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Oxygenator issue
REPORT NO
035
1/10/17
Medtronic Fusion Oxygenator Blood To Gas Leak
REPORT NO
034
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REPORT NO
033
Fannin Heparin Ampules Shattering
REPORT NO
032
Sucker Placed In Raceway In Wrong Direction
REPORT NO
031
High Transmembrane Pressure Gradients
REPORT NO
030
Faulty Connector On ECMO Soft Shell Reservoir Bag
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