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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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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