Catalog Number L5C4531 |
Device Problems
Scratched Material (3020); 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 01/20/2019 |
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 three (3) units of homechoice cassettes were damaged; further described as ¿some of the tubing had a cut or scratch on it¿.This was observed during set up for 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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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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