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.
Medtronic Affinity Pixie Oxygenator
Product Code: BBP241
Lot/Batch No: 2110252939
All devices removed from stock. Manufacturer informed. Hospital incident report filed. MHRA informed.
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