PERFUSION REPORTS

REPORT

001

DATE

1/1/2009

TITLE

Oxygenator Water To Blood Leak

DETAILS OF INCIDENT

Following a recent safety incident where, due to a heat exchanger fault, a water to blood leak occurred in an oxygenator.

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DETAILS OF INJURY TO PATIENT

TYPE OF DEVICE/MANUFACTURER

ACTION TAKEN

The Safety Committee would like to re-affirm that water-side leak are checked for before the oxygenator is primed for cardiopulmonary bypass and that the manufacturers¹ instructions for use (IFU) are followed when
setting up and priming an oxygenator.

The Safety Committee also recommends that departmental protocols clearly state the above.

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RESPONSE FROM MANUFACTURER

ADDTIONAL INFORMATION

SUPPORTING VISUALS/VIDEO

SUPPORTING DOCUMENT

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086

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1/7/21

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1/2/21

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1/6/21

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

1/5/21

IABP transport issue

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

1/4/21

Modified Ultrafiltration (MUF) Issue

REPORT NO

075



1/3/21

Electromagnetic interference with HLM

REPORT NO

074



1/2/21

HCU40 Failure

REPORT NO

073



1/2/21

HCU40 valve failures

REPORT NO

072



1/1/21

HCU40 failure

REPORT NO

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

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REPORT NO

070



1/1/21

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REPORT NO

069



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Centrifugal Head noise

REPORT NO

068



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Venous Reservoir disposable issue

REPORT NO

067



1/11/20

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REPORT NO

066



1/11/20

Failure of Valves on heater cooler unit

REPORT NO

065



1/9/20

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REPORT NO

064



1/9/20

Centrifugal head failure

REPORT NO

063



1/8/20

Centrifugal head issue 4

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