Catalog Number L5C4531 |
Device Problems
Disconnection (1171); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/30/2019 |
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 homechoice device experienced a system error 2240 (air in line/set) alarm.The home patient (hp) was connected at the time of the alarm.This occurred during fill two of five of peritoneal dialysis therapy.During the troubleshooting, it was reported that there was a disconnection between the heater line of the homechoice cassette and the heater bag that led to this alarm.Renal therapy services (rts) advised the hp to end therapy and to contact their nurse for further instructions.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 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 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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