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Catalog Number 5C4471R |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Unspecified Infection (1930); Renal Disease, End Stage (2039); Heart Failure (2206)
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Event Date 04/24/2014 |
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 therapy with a homechoice device (hc) passed away.The cause of death was reported to be cardiac failure, diabetes, renal disease, and an infection related to an amputation.It was unknown if therapy was ongoing until the time of death.It was not reported if an autopsy was performed.Additional information was requested but was not available.
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Manufacturer Narrative
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(b)(4).Should additional relevant information become available, a follow-up will be submitted.
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Manufacturer Narrative
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(b)(4).The device was returned to baxter healthcare for further investigation.A review of the event history log revealed no failure, malfunction or increased intraperitoneal volume (iipv) events that could have caused or contributed to the reported problem.Internal and external visual inspections were performed and revealed no problems.The device passed both the electrical and functional testing.Analysis of the device pneumatic system revealed no leaks and all pressures were correct and stable.The device passed seal, purge & wet disposable integrity tests.A short simulated therapy was performed on the device successfully.The results of the sample analysis revealed no failure or malfunction were identified that could have caused or contributed to the patient passing away.A review of the service history revealed no previous service events that would cause or contribute to the reported problem.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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