BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number L5C4531 |
Device Problems
Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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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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 dwell three of four of peritoneal dialysis therapy.During troubleshooting, it was reported that there was a loose connection between the supply line of the homechoice cassette and the supply bag, which is known to cause this alarm.The hp confirmed that the supply bag was properly connected before therapy started.The hp stated that they used a knife to open the supply boxes.There were no damages or leaks noted on the supplies.Renal therapy services assisted the hp with clearing the alarms and reviewed proper procedures per the user manual.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 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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