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 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device was discarded; therefore, a device analysis could not be completed.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 an unspecified line of a homechoice cassette had a "pinhole" which resulted in leak.This occurred during patient connection of peritoneal dialysis therapy.The leak was further described as solution "dribbling" out of the tubing.The patient ended the therapy session.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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H10: 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 discarded; 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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