BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2012389 · Received March 9, 2011

    Report

    Report Number
    1423500-2011-02953
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    December 29, 2010
    Report Date
    February 17, 2011
    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 WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED IN THE DEVICE LOG WAS DETERMINED TO BE INSUFFICIENT DRAIN: FALSE EMPTY DETECT AT INITIAL DRAIN AND AT PREVIOUS THERAPY LAST DRAIN. A REVIEW OF THE PREVIOUS SERVICE RECORD SHOWS THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE. NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUES OF IIPV. 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)).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE EVALUATION IS IN PROCESS; HOWEVER, NOT YET COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    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) 2010 STARTED AT 5:28:20 WITH DRAIN VOLUME OF 3238 ML DURING CYCLE 3. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED.

    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 77 YR