(b)(4).The field service representative (fsr) could not duplicate the reported complaint condition.The unit operated to the manufacturer's specifications.The flow sensor was located between the pump and oxygenator.There was no damage noted to the flow sensor, cable or connector.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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It was reported that before use of the device for a cardiopulmonary bypass (cpb) procedure, the flow readings were fluctuating.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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