BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2853434 · Received November 30, 2012

    Report

    Report Number
    1416980-2012-06281
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 14, 2012
    Report Date
    November 7, 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
    CO
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE WAS RECEIVED AND EVALUATED. THIS IS AN ANCILLARY SERVICE EVENT. THE IIPV EVENT WAS CONFIRMED IN THE DEVICE'S EVENT LOG. THE CAUSE WAS ONE OR MORE CYCLES ADVANCES TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MIN DRAIN VOLUME THRESHOLD.

    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 AT 20:12:55. DURING NIGHT DRAIN CYCLE FIVE, THE PATIENT'S ULTRAFILTRATION READING WAS 1240 ML, INDICATING THE HOME PATIENT (HP) DRAINED 1240 ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1900 ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1