BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3130647 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13429
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION COULD NOT CONFIRM THE REPORTED CONDITION AND ASSIGNABLE CAUSE COULD NOT BE DETERMINED DUE TO SAMPLE UNAVAILABILITY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN THE CASSETTE SET) ON THE HOMECHOICE (HC) DURING DWELL 4 OF 6 WHILE THE HP WAS CONNECTED. THE HP STATED THAT THE SUPPLY BAGS WERE EMPTY, AND THE HEATER BAG WAS THE ONLY BAG WITH SOLUTION. ALL OF THE BAGS WERE PROPERLY ATTACHED. THE HP HAD TO CYCLE THE POWER TWICE TO CLEAR SYSTEM ERROR 2240 AND SYSTEM ERROR 2367. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232478 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR HOMECHOICE