BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3873593 · Received June 15, 2014

    Report

    Report Number
    1416980-2014-19083
    Event Type
    Malfunction
    Date Received
    June 15, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS EVALUATED AND THE ISSUE WAS IDENTIFIED THROUGH REVIEW OF THE EVENT HISTORY LOGS. THE CAUSE WAS DETERMINED TO BE A FALSE EMPTY DETECT AT INITIAL DRAIN AND I-DRAIN ALARM VOLUME WAS MET. ALL RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THE DEVICE ALSO RECEIVED AN INTERNAL/EXTERNAL INSPECTION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    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) 2014 AT 21:46:14. DURING NIGHT DRAIN CYCLE ONE, THE PATIENT'S ULTRAFILTRATION READING WAS 1806ML, INDICATING THE HOME PATIENT (HP) DRAINED 1806ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2000ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351870 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR