BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2070785 · Received April 27, 2011

    Report

    Report Number
    1423500-2011-05087
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    December 2, 2010
    Report Date
    April 6, 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
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE DEVICE HAS BEEN RECEIVED, AND AN INVESTIGATION IS BEING CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE LOGS REVEALED A SINGLE OCCURENCE OF INCREASED INTRAPERITONEAL VOLUME (IIPV).THE DEVICE PASSED THE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL AND FUNCTIONAL TESTS. THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE AND IDENTIFIED NO FAILURE OR MALFUNCTION THAT COULD HAVE CAUSED/CONTRIBUTED TO THE IIPV. THE DEVICE MET SPECIFICATIONS RELATIVE TO THE IDENTIFIED IIPV. THE ASSIGNABLE CAUSE WAS DETERMINED AS INSUFFICIENT DRAIN, MULTIPLE CYCLES ADVANCING TO FILL DUE TO SLOW OR NO FLOW. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A SINGLE INCIDENT OF INCREASED INTRAPERITONEAL VOLUME WAS IDENTIFIED DURING A REVIEW OF THE PATIENT THERAPY EVENT LOGS, AS OCCURING DURING THERAPY WHICH STARTED ON (B)(6) 2010 AT 18:09 WITH A 1692 ML OF ULTRA FILTRATION, DURING CYCLE 2.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR LOCAL (PD4) AMBUFLEX| LOCAL (PD4) ULTRA BAG