BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3083615 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10741
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM, FOLLOWED BY A SE 2367 ALARM, ON THE HOME CHOICE (HC) IN DWELL 3 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM, HOWEVER, THE TSR WAS UNABLE TO FIND THE CAUSE OF THE ALARM THROUGH TROUBLE SHOOTING. THE TSR INSTRUCTED THE CAREGIVER (CG) TO CLOSE ALL THE CLAMPS TO THE BAGS/PATIENT LINE, CYCLE THE POWER OFF/ON, AT PRESS GO TO START, THEN AT LOAD THE SET, AND THEN THE CG REMOVED THE CASSETTE. THE TSR ADVISED THE CG TO DISPOSE OF THE CURRENT SUPPLIES AND START OVER WITH ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO ADVERSE EVENT WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183512 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR HOMECHOICE