BAXTER HEALTHCARE - MOUNTAIN HOME AMIA AUTOMATED PD CYCLER SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number 5C5479 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Patient Involvement (2645)
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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 the tubing of the amia cassette was stuck to the heater bag and when the tubing was removed, it ripped a hole in the heater bag.The set was not used in therapy.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Additional information. the device was received for evaluation.A visual inspection performed with the naked eye noted a hole in the heater bag.The reported issue was verified.The direct cause of the event was determined to be manufacturing related; caused by excess solvent on the tubing to the heater bag.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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