Catalog Number R5C4479C |
Device Problems
Fluid/Blood Leak (1250); Scratched Material (3020)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event/therapy date was known to be before 05/09/2019.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 the patient line of the homechoice cassette was leaking.This occurred during an unknown process step of peritoneal dialysis therapy.It was further reported that the patient line also had a "scratch" on it.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Additional information: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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