Catalog Number 115269 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Death (1802)
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Event Date 03/04/2020 |
Event Type
Death
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that during continuous renal replacement therapy, a patient passed away while connected to a prismaflex control unit.The cause of death was not reported.It was not reported if an autopsy was performed.No additional information is available.
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Manufacturer Narrative
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The actual device was inspected on-site by a qualified baxter technician and no issues were identified.A full technical check of the device was performed and the device was found to meet manufacturer's specifications.The machine was then calibrated and returned to clinical service.A device history review revealed no complaints associated with the device in the previous 24 months.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Additional information added to f tab: importer/reporter number.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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