Catalog Number 5C4476 |
Device Problems
Fluid/Blood Leak (1250); 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 02/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device was discarded; therefore, a device analysis could not be completed.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 an effluent sample bag had a small cut which resulted in a leak.This was noticed during use of the device 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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Additional information: 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 discarded; 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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