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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 10/14/2015 |
Event Type
malfunction
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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.Upon conclusion of the investigation, the cause of this issue was determined to be use error, tidal total ultrafiltration removal set too low.The homechoice apd systems trainer¿s guide gives instructions on how to set the tidal therapy settings.A review of the label for the product family will be conducted.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 19:33:12.During night drain cycle five, the patient's ultrafiltration reading was 1629ml, indicating the home patient drained 1514ml more than their maximum programmed fill volume of 2300ml.No additional information is available.
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Search Alerts/Recalls
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