PERFUSION REPORTS

REPORT

097

DATE

19/3/2022

TITLE

Disposables Issue

DETAILS OF INCIDENT

Good Catch

A leak has been spotted from the silicone tubing of the pump boot at the point of the connector (inlet or outlet). This has now occurred on 3 separate occasions with 2 different LOT numbers. When spotted on the inlet to the pump air entrained into the circuit.

When spotted on the outlet prime was leaking/squirting out of the hole.

All 3 leaks were spotted prior to bypass. Subsequent inspection of sterile sets have identified more potentially damaged silicone boots. 2 separate batch/lot no's were involved.

DETAILS OF INJURY TO PATIENT

None

TYPE OF DEVICE/MANUFACTURER

Terumo Silicone Pump Boot

ACTION TAKEN

The product has been removed from use within the hospital.

Terumo are conducting an inquiry.

RESPONSE FROM MANUFACTURER

Waiting

ADDTIONAL INFORMATION

SUPPORTING VISUALS/VIDEO

SUPPORTING DOCUMENT

OTHER PERFUSION
REPORTS

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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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