It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the cord was separated from the connector.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 confirmed.During laboratory analysis, the product surveillance technician (pst) observed the cable was separated from strain relief.The centrifugal motor functioned as intended.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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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