BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4102122 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32251
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    March 25, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. REVIEW OF THE EVENT LOG FOUND EVIDENCE OF THE REPORTED IIPV CONDITION. THE CAUSE WAS DETERMINED TO BE FALSE EMPTY DETECT AT INITIAL DRAIN AND I-DRAIN ALARM VOLUME WAS MET. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT 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 10:56:49. DURING NIGHT DRAIN CYCLE ONE, THE PATIENT'S ULTRAFILTRATION READING WAS 1720ML, INDICATING THE HOME PATIENT (HP) DRAINED 1720ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2500ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584212 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR