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.

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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

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RESPONSE FROM MANUFACTURER

ADDTIONAL INFORMATION

SUPPORTING VISUALS/VIDEO

SUPPORTING DOCUMENT

OTHER PERFUSION
REPORTS

Select and scroll to view chosen report

REPORT NO

123



5/7/24

Hardware Fault

REPORT NO

122



5/4/24

Oxygenator Failure

REPORT NO

121



8/3/24

Disposables: Eurosets Adult ECMO Oxygenator

REPORT NO

120



1/5/24

Disposable Incident

REPORT NO

119



Hardware: HCU Contamination

REPORT NO

118



12/9/23

Human Factors: ECMO Mobilisation

REPORT NO

117



27/9/23

Disposables: Oxygenator

REPORT NO

116



14/9/23

Disposable Issue: Reservoir in CPB circuit

REPORT NO

115



13/9/23

Disposable Error

REPORT NO

114



13/7/23

Dispoables

REPORT NO

112



20/2/23

HLM Hardware Error: S5 HLM - Dual roller cardioplegia

REPORT NO

111



10/2/23

Human Factors

REPORT NO

110



31/1/23

DISPOSABLE FAULT

REPORT NO

109



19/1/23

Disposable issue

REPORT NO

108



3/1/23

Disposable issue: Oxygenator leak

REPORT NO

107



6/12/22

Hardware fault. Electronic gas Blender failure

REPORT NO

106



1/11/22

ECG Interference

REPORT NO

105



9/9/22

Issue with use of disposable

REPORT NO

104



13/6/22

Human Factors

REPORT NO

103



25/7/22

Human Factors

REPORT NO

102



7/7/22

Disposable issue

REPORT NO

101



6/4/21

Irregular blood flow/foreign looking substance in Oxygenator

REPORT NO

100



20/4/22

Gas Line Filter Fault

REPORT NO

099



20/4/22

Human Factors: BiVAD Error

REPORT NO

098



4/4/22

REPORT NO

097



19/3/22

Disposables Issue

REPORT NO

096



18/3/22

Bubbles Sensor Activation

REPORT NO

095



1/1/22

Protamine Administration

REPORT NO

094



1/11/21

Oxygenation failure upon commencement of CPB

REPORT NO

093



1/11/21

Detached bullet tip of sump-updated response Sep 2022

Perfusion Report cards are shown in batches of 30 at any one time where available.

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