Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).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 2008t machine passed functional testing during the on-site evaluation.The fst did not identify any issues with the machine that could have caused or contributed to the reported event.The machine was determined to be operating within specification and an associated cause could not be determined.Clinical investigation: a temporal relationship does not exist between hd therapy utilizing the 2008t hd machine and the patient¿s death as it was reported the patient expired two hours after disconnection from the machine.The etiology and timeline of the event(s) remains unknown; therefore, causality cannot be established.Presently there is no objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction caused or contributed to the patient¿s expiration.Given the absence of a discharge summary, primary/secondary cause of death, esrd death notification, death certificate and no autopsy report.The 2008t hemodialysis system cannot be excluded from having a possible causal or contributory role in the patient¿s expiration, as there is insufficient evidence to conclude the root cause of the event(s).However, it is well-known the esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population.
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A hospital biomedical technician requested onsite service from a fresenius field service technician (fst) to evaluate a 2008t hemodialysis (hd) machine.It was reported that a patient expired approximately two hours after an hd treatment was provided on the system.There was no specific allegation this event was related to any deficiency or malfunction of fresenius device(s) or product(s) in the initial reporting.Subsequent attempts to obtain additional information (e.G.Demographics, medical history, end-stage renal disease (esrd) death notification, discharge summary, autopsy report and/or death certificate) have thus far proven unsuccessful.The hospital provided 2008t hd machine was inspected by an fst and it was verified the machine was operating properly.
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