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Catalog Number 5C4471R |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/25/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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During evaluation of a returned homechoice device, one increased intra-peritoneal volume (iipv) event was identified which occurred in the therapy initiated on (b)(6) 2015 at 21:33:41.During night drain cycle three, the patient's ultrafiltration reading was 1389ml, indicating the home patient drained 1389ml more than their maximum programmed fill volume of 2000ml.No additional information is available.
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Manufacturer Narrative
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(b)(4).The device was received and the evaluation is complete.During the event history log review, an increased intra-peritoneal volume (iipv) event was identified.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the event.The homechoice device received a returned instrument testing evaluation (rite).This evaluation includes functional and electrical testing on the device.Upon conclusion of the investigation, the cause of the iipv event was one or more cycles advanced to the next fill when a slow or no flow occurred above the minimum drain volume threshold.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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