Catalog Number L5C4531 |
Device Problems
Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device was received and is currently awaiting evaluation.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 a homechoice cassette had a ¿pin hole¿ in the patient line.This issue was observed during dwell of peritoneal dialysis (pd) therapy.The patient was connected for therapy at the time of this event.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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B5: further information was received regarding the event which reported that there was hole in the patient line of an unspecified number of homechoice cassettes which caused leaks (leaks previously not reported).This occurred on unspecified dates.It was reported that the patient received unspecified antibiotics as a prophylactic treatment only.H10: one device was received and evaluated.A visual inspection with the naked eye noted a pinhole in the patient line tubing.Functional testing including clear passage testing and clamp function testing were performed with no issues noted.Leak testing failed due a pin hole in the patient line tubing.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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