BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1883160 · Received October 26, 2010

    Report

    Report Number
    1423500-2010-04940
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 6, 2010
    Report Date
    October 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    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). THE DEVICE WAS RECEIVED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE DEVICE PASSED BOTH THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST (B)(4) AND THE RITE FUNCTIONAL TEST (B)(4). THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE IIPV FOUND IN THE DEVICE LOGS. THE DEVICE FUNCTIONED NORMALLY DURING PAL TESTING. THE ASSIGNABLE CAUSE OF THE IIPV IN THE LOGS WAS DETERMINED TO BE: INSUFFICIENT DRAIN - FALSE EMPTY DETECT AT INITIAL DRAIN AND AT PREVIOUS THERAPY LAST DRAIN. 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 (B)(4). A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE THAT COULD BE RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE DEVICE, A BAXTER TECHNICIAN IDENTIFIED AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WHICH OCCURRED DURING DRAIN CYCLE 1. THE DRAIN VOLUME WAS 4265 ML. THIS DRAIN VOLUME MEETS OVERFILL CRITERIA. AT THE TIME OF THE INITIAL CALL RELATED TO THIS DEVICE, THERE WAS NO REPORT OF PATIENT INJURY OR ALLEGATION OF OVERFILL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR