Catalog Number 5C5479 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2023 |
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 two (2) amia automated pd cycler sets were leaking from an unspecified location and the drain line was cracked.These issues were observed after peritoneal dialysis therapy was completed.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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Additional information was added to h6 and h10.H10: 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 received for evaluation; 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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