BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2594775 · Received May 31, 2012

    Report

    Report Number
    1423500-2012-11567
    Event Type
    Malfunction
    Date Received
    May 31, 2012
    Date of Event
    April 29, 2012
    Report Date
    May 4, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Removal / Correction Number
    1423500-01/08/10-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROGRESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). REVIEW OF THE DEVICE'S THERAPY LOG REVEALED THE USER HAD AN ULTRAFILTRATION (UF) VOLUME OF 1428 ML DURING THERAPY INITIATED ON (B)(6) 2012 20:25, WHICH WAS SUSPECTED TO BE AN INCREASED INTRAPERITONEAL VOLUME (IIPV) OF FLUID. AN IIPV IS ANY THERAPY WHERE THE PATIENT VOLUME EXCEEDS 160% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME, AS DEFINED IN THE 1154817 CLINICAL HAZARDS LIST. A REVIEW OF THE DEVICE'S EVENT LOG WAS PERFORMED FOR THE THERAPY INITIATED ON (B)(6) 2012 20:25. THE LAST CYCLE (6) WAS ENDED BEFORE THE END OF THE THERAPY. THEREFORE, THE UF FROM DRAIN 6/6 GETS LUMPED TOGETHER WITH THE UF FROM THE PREVIOUS CYCLE, (1430 ML + 0 ML = 1430 ML). REVIEW OF THE EVENT LOG REVEALED THE USER?S ACTUAL DRAIN VOLUME DURING CYCLE 4 WAS 2948 ML. THE ACTUAL DRAIN VOLUME OF 2948 ML IS 155% OF LARGEST PRESCRIBED FILL VOLUME (LPFV) OF 1900 ML; THEREFORE, THIS INCIDENT DOES NOT MEET IIPV CRITERIA. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2012 20:25:19. DURING NIGHT DRAIN CYCLE FIVE, THE PATIENT'S ULTRAFILTRATION READING WAS 1428ML, INDICATING THE HOME PATIENT (HP) DRAINED 1428ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1900ML.THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1