PERFUSION REPORTS

REPORT

028

DATE

TITLE

Sorin Inspire 8F Oxygenator Detached From Holding Arm

DETAILS OF INCIDENT

For a period of time Sorin Inspire 8F oxygenators were arriving detached from the plastic holding arm. As a consequence the oxygenator could not be mounted either in a holder or onto the reservoir.
This connection should be a permanent connection.
We were advised by the company that as long as they did not arrive detached the bond would be secure. Two incidences then occurred where the device was checked and appeared intact but subsequently became detached - once during building and once during priming.

DETAILS OF INJURY TO PATIENT

None

TYPE OF DEVICE/MANUFACTURER

N/A

ACTION TAKEN

Supplier contacted on each occasion. This covered numerous lot numbers. After the incidences of detachment during building and priming we contacted the supplier again.

RESPONSE FROM MANUFACTURER

They were unable to assure us that the problem had been fully identified and resolved and could not guarantee that there was no risk of an oxygenator falling off the holder during use. We have discontinued the use of the device and all packs have been returned to Sorin.

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ADDTIONAL INFORMATION

N/A

SUPPORTING VISUALS/VIDEO

N/A

SUPPORTING DOCUMENT

OTHER PERFUSION
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REPORT NO

123

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5/4/24

Oxygenator Failure

REPORT NO

121

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8/3/24

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120



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Disposable Incident

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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

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114



13/7/23

Dispoables

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112



20/2/23

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REPORT NO

110



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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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