According to the customer: "there was heavy bleeding during the cardiovascular surgery (case: right side of renal cancer, method: right radical nephrectomy (transthoracic and transabdominal approach), ivc ~ right atrium tumour embolus extirpation).Then, the customer started using the extracorporeal circulation circuit and controlling the condition of the patient.Three (3) hours after the pump started, the co2 removal and the oxygenation decreased in performance drastically.It was observed that bubbles (just like plasma leak) were leaking from the membrane of the oxygenator.There was no pressure increase at the inlet and outlet of the oxygenator.The patient expired after the surgery due to bleeding the customer considers that there is no causal connection between the incident and the patient's death." (b)(4).Also referencing to (b)(4) for leakage gas and exhaust port.
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The returned product was visual inspected in the laboratory of the manufacturer.No clots or other abnormalities were detected.To ensure performance of the products prior to shipment, checks, controls, and performance tests are carried out during the manufacture of the products.These tests can be reviewed as part of a dhr review.Dhr review results: affected product: basic lot 70116605 and packaging lot 70116606 (serial number (b)(4)).The avz from (b)(6) (dms# (b)(4)) was reviewed on (b)(6) 2017.There were no references found, which are indicating a nonconformance of the product in question.Additionally a review of the weekly performance monitoring according to si-c-09 has been reviewed (dms# (b)(6)), the performance tests passed the acceptance criteria.Thus the reported failure could not be confirmed.Based on the results obtained during investigation at this time the cause of the reported incident was determined to not be attributed to a device related malfunction.Since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action is needed at this time.
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