BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2140039 · Received June 25, 2011

    Report

    Report Number
    1423500-2011-08364
    Event Type
    Malfunction
    Date Received
    June 25, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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 IS IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION), FUNCTIONAL AND ELECTRICAL TESTS AND WAS FUNCTIONING WITHIN SPECIFICATION. A REVIEW OF THE DEVICE LOGS REVEALED A DRAIN VOLUME THAT MEETS THE IIPV (INCREASED INTRA-PERITONEAL VOLUME) CRITERIA. THE CAUSE FOR THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN - FALSE EMPTY DETECT AND USE ERROR, CLINICIAN INAPPROPRIATELY SET MINIMUM DRAIN VOLUME % SETTING TOO LOW. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE IIPV. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RTB-CAPA-(B)(4).

    Description of Event or Problem · 1

    DURING EVALUATION, AN ADDITIONAL ISSUE OF AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT WAS FOUND IN THE PATIENT EVENT LOGS: OCCURRENCE DATE (B)(6) 2011 WITH DRAIN VOLUME OF 2635 MILLILITERS (ML) DURING CYCLE 5.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR