BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2151754 · Received July 6, 2011

    Report

    Report Number
    1423500-2011-08712
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 10, 2011
    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 DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) FOUND IN THE DEVICE LOGS. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RETURN INSTRUMENT TEST / EVALUATION (RITE) TESTING. THE DEVICE PASSED BOTH THE HOMECHOICE (RITE) ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED IN THE DEVICE LOG WAS DETERMINED TO BE: INSUFFICIENT DRAIN, MULTIPLE CYCLES ADVANCED TO FILL WHEN SLOW/NO FLOW. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA. A DEVICE HISTORY REVIEW WAS PERFORMED, FINDING THAT NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED DURING THE MANUFACTURING OF THIS DEVICE.

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE MACHINE, A BAXTER TECHNICIAN FOUND AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) THAT WAS IDENTIFIED IN PATIENT THERAPY LOG ON (B)(6) 2011 AT 15:25:33 WITH DRAIN VOLUME OF 2605 ML DURING CYCLE 3. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED. THIS EVENT MEETS OVERFILL CRITERIA.

    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