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Catalog Number L5C4531 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/10/2019 |
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 a home patient (hp) experienced air in the patient line of a homechoice (hc) cassette, without an alarm.The hp was connected at the time of the event.This occurred during initial drain of automated peritoneal dialysis therapy.There was nothing unusual found during troubleshooting that would cause or contribute to the event.The hp stated that they noted over an inch of air in the patient line.They re-primed the line and the line primed successfully.Renal therapy services (rts) advised the hp to set up the hc with new supplies.Rts assisted the hp to end the therapy, disconnect using aseptic technique, and remove the cassette.Rts reviewed proper procedures per the user manual with the hp.There was no patient injury or medical intervention associated with this event.No additional information was 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 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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