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Catalog Number 5C8310 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Death (1802); Heart Failure (2206); Multiple Organ Failure (3261)
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Event Date 01/08/2014 |
Event Type
Death
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Event Description
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It was reported that a peritoneal dialysis (pd) patient (pt) who performed pd therapy with a homechoice (hc) device passed away due to cardiac disease.On an unknown date in the month prior to death, the pt was hospitalized for another indication.On an unreported date in the same month as being admitted, the pt was discharged from the hospital and went home on hospice care.Subsequently, the pt died.The cause of death was reported to be due to cardiac disease.The cause of death was further described as possibly due to multi-system organ failure, however, this was not confirmed.Pd therapy was ongoing until the time of death.The pt was not connected to the hc at the time of death.It was unknown if an autopsy was performed.Additional information was requested but is not available.
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Manufacturer Narrative
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(b)(4).Should additional relevant information become available, a follow-up medwatch will be submitted.
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Manufacturer Narrative
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(b)(4).A review of the device history revealed no issues that could have caused or contributed to the patient passing away.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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(b)(4).The serial number ((b)(4)) and catalog number (5c8310r) that were previously reported were incorrect and the actual sn and catalog number associated with this patient were sn (b)(4) and catalog number 5c8310.As the device was not linked to the reported death until after the device had been serviced, a complete device analysis could not be completed to investigate the reported death.However, a review of the device logs revealed no system errors, anomalies, hardware device failures or intraperitoneal volume iipv events that could have caused or contributed to the reported difficulty.The device passed both the homechoice rite (return instrument test/evaluation) electrical test and the homechoice rite functional test and was determined to meet performance specification requirements per rite testing.Review of the service history revealed no issues that could have caused or contributed to the home patient passing away.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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