Catalog Number 5C5479 |
Device Problem
Misassembled (1398)
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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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(b)(4).The reported event occurred on an unreported date in (b)(6) 2017.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 was misassembled with a missing patient line cap.The home patient clarified that the caps were still present in the packaging; however, they were missing from the patient line cap.This occurred during setup for peritoneal dialysis therapy.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 added to evaluation codes.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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