BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2020840 · Received March 16, 2011

    Report

    Report Number
    1423500-2011-03276
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 23, 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 FAILED THE HOMECHOICE RITE FUNCTIONAL TEST. THE HOMECHOICE RITE ELECTRICAL TEST PASSED. A SHORT SIMULATED PATIENT THERAPY WAS PERFORMED AND COMPLETED SUCCESSFULLY. ADDITIONAL ISSUE IIPV: (OCCURRENCE DATE (B)(6) 2011 / CYCLE 4 / DRAIN VOLUME 3314 ML) WAS CONFIRMED IN THE LOGS AND NOT DUPLICATED DURING THE PAL EVALUATION. ROOT CAUSE WAS INSUFFICIENT DRAIN. ONE OR MORE CYCLES ADVANCE TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. THE DEVICE WAS IN SPECIFICATION RELATIVE TO IIPV. THE DEVICE WAS SUBSEQUENTLY FORWARDED TO SERVICE. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. 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 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.

    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 08:52:49 WITH DRAIN VOLUME OF 3314 ML DURING CYCLE 4. 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 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR