PERFUSION REPORTS

REPORT

055

DATE

1/2/2020

TITLE

Faulty Pressure Relief Valves

DETAILS OF INCIDENT

The pressure relief valve in the top of the reservoir fell through into the main body of the reservoir during priming. This was replaced with a new oxygenator and the same thing happened. One of these oxygenators was already in use in theatre. It was immediately checked and it was at this point that the valve fell through into the reservoir of the venous blood. The patient was already cooled to deep hypothermia to allow circulatory arrest, so there was no additional time off CPB to change out the device.

DETAILS OF INJURY TO PATIENT

None

TYPE OF DEVICE/MANUFACTURER

Medtronic Affinity Pixie Oxygenator

Product Code: BBP241

Lot/Batch No: 2110252939

ACTION TAKEN

All devices removed from stock. Manufacturer informed. Hospital incident report filed. MHRA informed.

RESPONSE FROM MANUFACTURER

Not yet available

ADDTIONAL INFORMATION

SUPPORTING VISUALS/VIDEO

SUPPORTING DOCUMENT

Images:faulty pressure relief valve

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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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