It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the unit was not reading any flows.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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Updated event problem and evaluation codes.The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the module displayed flow and signal strength of over 100% with the flow printed circuit (pc) board installed in a lab-use centrifugal control module.No loss of flow display occurred during the two days of testing.The unit operated to the manufacturer's specifications.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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