Catalog Number L5C4531 |
Device Problems
Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017); Improper Flow or Infusion (2954)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/09/2019 |
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 leaking.After priming was complete, it was discovered that the patient line was not in the holder and solution leaked out which resulted in air in the tubing.Renal therapy services (rts) advised the patient to start over with new supplies.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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