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Catalog Number 5C8310R |
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 11/25/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device was received and is in the process of being evaluated.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.This event occurred in the therapy initiated on (b)(6) 2015 at 01:58:13.During night drain cycle four, the patient's ultrafiltration reading was 1292ml, indicating the home patient (hp) drained 1292ml more than their maximum programmed fill volume of 2100ml.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.The homechoice device received a returned instrument testing evaluation (rite).This evaluation included functional and electrical testing of the device.A visual inspection was performed.A service history review revealed no indication that the parts replaced during servicing caused or contributed to this event.Upon conclusion of the investigation, the cause of this issue was determined to be that one or more cycles advances to next fill when slow/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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