BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2791919 · Received October 15, 2012

    Report

    Report Number
    1416980-2012-02476
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 5, 2012
    Report Date
    September 24, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS CONDITION IS AN ANCILLARY SERVICE EVENT. THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS A FALSE EMPTY DETECTED AND A USE ERROR, AS INAPPROPRIATE BYPASS OF THE CAUTION: NEGATIVE ULTRA-FILTRATION (UF) ALARM.

    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. DURING NIGHT DRAIN CYCLE THREE, THE PATIENT'S ULTRAFILTRATION READING WAS 2129ML. THIS INDICATES THAT THE HOME PATIENT (HP) DRAINED 2129ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 3000ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR