PERFUSION REPORTS

REPORT

056

DATE

1/1/2020

TITLE

Centrifugal Head Issue

DETAILS OF INCIDENT

Two Liva Nova centrifugal head disposables that were noticed to make an unusual sound during priming. The first one (07/01/2020) was observed to wobble (video footage sent to company). The second disposable (24/01/2020) was not noticed to wobble but there was an audible hum that replacement with a new centrifugal head removed. In both cases the issue was noticed during priming and the disposable was able to produce flow but the suspected flaw was felt to be potentially dangerous.

DETAILS OF INJURY TO PATIENT

None

TYPE OF DEVICE/MANUFACTURER

Liva Nova Revolution Centrifugal Head

Product Code: AB1579

Lot/Batch No: 1902150167/1908020195

ACTION TAKEN

Replacment of centrifugal heads in both instances during priming removed sound and wobble. Company contacted after initial disposable failure and collection for assessment arranged. Second disposable error prompted safety report due to repeat quality issue.

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RESPONSE FROM MANUFACTURER

ADDTIONAL INFORMATION

SUPPORTING VISUALS/VIDEO

SUPPORTING DOCUMENT

044 Manufacturers Response

OTHER PERFUSION
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REPORT NO

123

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122

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121

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120



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119

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118

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12/9/23

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REPORT NO

117

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27/9/23

Disposables: Oxygenator

REPORT NO

116



14/9/23

Disposable Issue: Reservoir in CPB circuit

REPORT NO

115

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13/9/23

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114

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13/7/23

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20/2/23

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31/1/23

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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

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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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