Catalog Number R5C4479C |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/07/2019 |
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 a homechoice cassette was damaged.This was noticed during prime of peritoneal dialysis therapy.The patient was not connected during the time of the event.The damaged cassette was further described as there was a small cut or a notch in tubing.There was no report of patient injury or medical intervention associated with this event.No additional information was 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 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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