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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 11/30/2015 |
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 01:37:17.During night drain cycle seven, the patient's ultrafiltration reading was 1692ml, indicating the home patient drained 1692ml more than their maximum programmed fill volume of 1500ml.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.This is an ancillary service event.The increased intra-peritoneal volume (iipv) event was identified through an event history log review.The homechoice device received a returned instrument testing evaluation (rite), including functional and electrical testing of the device.The device was determined to meet functional performance specification requirements per rite testing.Internal and external visual inspection was performed and no issues were noted.A short simulated therapy was performed and completed successfully.A service history record review was performed and revealed no indication that the parts replaced during servicing caused or contributed to this event.Upon conclusion of the investigation, the cause 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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