BAXTER HEALTHCARE - SINGAPORE HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number R5C4479 |
Device Problems
Crack (1135); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/31/2019 |
Event Type
malfunction
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Manufacturer Narrative
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An alarm indicative of a potential malfunction of the disposable cassette was reported.The actual device was not available; however, photographs of the sample were provided for evaluation.A visual inspection of the photographs was performed which revealed a crack on the side of the welded cassette.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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 dwell phase of peritoneal dialysis therapy.During the troubleshooting, it was reported that a crack was identified on the homechoice cassette when it was removed, which lead to the alarm.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Search Alerts/Recalls
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