The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. clinical investigation: upon the initial reporting, there was no specific allegation this hospitalization was due to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Multiple attempts were made to obtain the required information for this reported event; however, no additional information was acquired.Presently there is no allegation or objective evidence indicating a serious injury, patient death, or other adverse event(s) occurred related to a fresenius product(s) or device(s) warranting further investigation.Additionally, there is no allegation a fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s hospitalization.
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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