Catalog Number L5C4531 |
Device Problems
Fluid/Blood Leak (1250); Hole In Material (1293)
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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 event occurred on unspecified date(s) in (b)(6) 2018.The device was not received for evaluation.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 leaked due to holes.This occurred during set up of peritoneal dialysis therapy.The patient would have two to three defective cassettes before they finding at least one working cassette that would go through.The patient tried to use the cassettes but they would get an alarm and error message to change the cassette.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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