BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number L5C4531 |
Device Problems
Fluid/Blood Leak (1250); Hole In Material (1293); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/26/2017 |
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 patient was connected at the time of the alarm.This occurred during initial drain of peritoneal dialysis therapy.The home patient stated that there is a hole in the patient line, located right under the white connector, and this is the location of the leak.The patient will start over with all new supplies.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 returned; therefore, a device analysis could not be completed.However, it was reported that there was a hole in the patient line which is a known cause of the reported alarm.The cause of the hole could not be determined, should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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