It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the compressor of the heater-cooler would not start.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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The reported complaint was not verifiable.Multiple diligence attempts were made in obtaining the part return status, but were unsuccessful therefore no evaluation could be performed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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