BAXTER HEALTHCARE CORPORATION AMIA AUTOMATED PD CYCLER SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number 5C5479 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that an amia automated pd set with cassette had damage; described as "on the left side of the cassette that has three ports, the top ports tubing has a nick/hole in it".This was observed prior to use of the device for peritoneal dialysis therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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The event occurred on an unspecified date in (b)(6) 2023, reported as "a few days ago." the device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the sample was received for evaluation, unused, with the original caps attached to the connectors.A visual inspection with the naked eye noted a damage surface cut to the patient line tubing approximately 1 ½ inches from the cassette port.Functional testing including leak and clear passage testing were performed to the patient line only with no issues noted.The reported condition was verified.The direct cause was determined to be a manufacturing related issue caused by grippers during the automated assembly.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this 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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