It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, discolored water was noted in the unit.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.Per the manufacturer's subsidiary, the no parts will not be returned to manufacturer for evaluation.It was deemed by the user facility's engineer that the fitting elbow was the cause of the problem.The repair was made and the fitting elbow with local sealant was put in its place.The facility continued using the unit and it worked properly.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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