Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).According to complaint report, dated on(b)(6)2018 , the issue has been detected prior to use.No patient involvement.The sets (incl.Quart) were replaced before patient treatment.The arterial filter quart (4 pieces) have been returned for further investigation at maquet laboratory.According to the investigation report, dated on 2019-01-28, the leakage of the quart could be confirmed.A leak test has been performed by the laboratory.A leakage was detected between the cover and the housing, near to the bypass-tap (white) of the quart.Thus the failure could be confirmed.Most probable root cause could be determined as bad welding between the cover and the housing.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.
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