Through follow-up communication livanova learned that the reported issue affected cardioplegia circuit only and not patient circuit.Pump malfunction and heating malfunction on cardioplegia circuit are not likely to result is death or serious injury since cardioplegia solution is delivered in small volumes and at regular intervals allowing the user to perfom heating through alternative methods or to use another circuit of the device.Thus, temperature management on cardioplegia side is not critical in clinical practice and the reported event is assessed as not reportable.In addition, livanova identified that this complaint was already captured in livanova complaint database.Therefore, this specific case has been voided.
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