BAXTER HEALTHCARE - MOUNTAIN HOME AMIA AUTOMATED PD CYCLER SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number 5C5479 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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 an unspecified quantity of amia cassettes had a connection issue with the transfer set.This occurred during an unknown process step of peritoneal dialysis therapy.The home patient (hp) stated that they were having difficulty with the connection of the patient line to the port of their transfer set.The hp stated that they had to force it to close tightly, but had concerns of it coming apart.During follow up, it was confirmed that there was no disconnection; however, the hp further described that "the little connection on the patient hose where the plastic lines sticks on had a white thing that was barely hanging".The hp confirmed that they properly tightened the connection.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 : the actual device was not available; therefore a device analysis could not be performed for that sample.However, a companion sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed on the companion sample including leak and clear passage tests with no issue noted; patient line connector was connected to an in-lab transfer set with no issues noted.The reported condition was not verified on the companion sample.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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Search Alerts/Recalls
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