BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3790192 · Received May 5, 2014

    Report

    Report Number
    1416980-2014-14461
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    August 27, 2013
    Report Date
    April 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. REVIEW OF THE EVENT LOG FOUND EVIDENCE OF THE REPORTED IIPV CONDITION. THE RETURNED HOMECHOICE HAS RECEIVED A FUNCTIONAL AND ELECTRICAL EVALUATION. THE DEVICE PASSED RITE (RETURN INSTRUMENT TEST/EVALUATION) ELECTRICAL TEST. THE CAUSE WAS DETERMINED TO BE ONE OR MORE CYCLES ADVANCES TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. 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, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2013 AT 20:36:57. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION READING WAS 1637ML, INDICATING THE HOME PATIENT (HP) DRAINED 1637ML 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
    267167 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR