Catalog Number 5C5479 |
Device Problems
Disconnection (1171); Loose or Intermittent Connection (1371)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/22/2019 |
Event Type
malfunction
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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 the cap on the patient line of an amia peritoneal dialysis cassette was loose and fell off.This was identified while the home patient (hp) was preparing for automated peritoneal dialysis therapy.The hp reported that upon attaching the organizer to the machine, the cap on the patient line completely fell off.The hp did not use this cassette.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 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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