Plant investigation: the device was not returned to the manufacturer for physical evaluation and a serial number could not be ascertained.As neither a device history record review nor a physical evaluation could be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted.A clinical review was performed to identify the necessity of performing a clinical investigation for the reported incident.Based on the provided information, there is currently no allegation or documentation that suggests that a fresenius device or product caused or contributed to the patient¿s death.As there is currently no causal relationship between the patient¿s passing and their hemodialysis treatment, a clinical investigation is not warranted.Should additional information become available, the need for a clinical investigation will be reevaluated.
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It was reported that a hemodialysis patient passed away from respiratory failure.Leading up to their passing, the patient was performing hemodialysis in an unspecified hospital.The patient was scheduled to be transferred to a clinic for further in-center hemodialysis treatments when they passed away.It was not reported if the patient was connected to a hemodialysis machine at the time of death.The exact date of the patient's passing was not provided.Furthermore, it is currently unknown if a fresenius machine was being utilized for hemodialysis treatments.Additional follow up attempts with the patient¿s peritoneal dialysis registered nurse were unsuccessful in obtaining additional information related to the event.
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