BAXTER HEALTHCARE - MOUNTAIN HOME AMIA AUTOMATED PD CYCLER SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number 5C5479 |
Device Problem
Material Integrity Problem (2978)
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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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(b)(4).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 "about four " amia cassettes may have not been properly sealed.The patient could not see any immediate damage on the product, however, thought that they did see where the seal on the cassette may have not been properly sealed, causing a missing red line alarm this issue was found during use after the machine prompts the patient to connect the solution.The amia automated pd system alarmed that the red line was missing.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.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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