Catalog Number 5C5479 |
Device Problem
Break (1069)
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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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The incidents occurred on a unreported date in (b)(6) 2018.The device has been received and the evaluation is in progress.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 cassettes were damaged.The damage was further described as the sheeting separated ("pulling up") from the cassettes.This was noticed during set up of peritoneal dialysis therapy.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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Two samples were received for evaluation.A visual inspection was performed with naked eye with no evidence of the cassette sheeting pulling away.Functional testing including leak testing, clear passage testing and clamp function testing were performed with no issues noted.The reported condition was not verified.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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