BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3802423 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14916
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RETURNED AND EVALUATED. ALL RETURNED HC DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THE DEVICE WAS ALSO VISUALLY INSPECTED. THE EVENT WAS IDENTIFIED DURING THE REVIEW OF THE EVENT HISTORY LOGS. THE CAUSE WAS DETERMINED TO BE UNEXPECTED HIGH ULTRA FILTRATION (UF) FOR THERAPY COMPARED TO OTHER THERAPIES. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT(S) WAS IDENTIFIED WHICH OCCURRED DURING THERAPY INITIATED ON (B)(6) 2014 AT 00:04:06. DURING NIGHT DRAIN CYCLE TWO, THE PATIENT'S ULTRAFILTRATION READING WAS 2732ML, INDICATING THE HOME PATIENT (HP) DRAINED 2732ML 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
    281536 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR