Investigation: the arterial filter quart has been returned for further investigation at maquet laboratory.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 the investigation report, dated on 2019-01-25, the leakage of the quart could be confirmed.During leak test at the laboratory it has been found a leakage between the cover and the housing, near 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.Correction: according to complaint report, dated on (b)(6)2018, the issue has been detected prior to use.No patient involvement.The set (incl.Quart) was replaced before patient treatment.Corrective action: since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.
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