BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2983648 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04982
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE EVENT WAS USE ERROR. THERE WAS NO REPORTED DEVICE MALFUNCTION THEREFORE NO FURTHER INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A CONNECTION ISSUE WHICH OCCURRED ON THE HOMECHOICE (HC) DURING FILL 1 OF 4. THE HC ALARMED WITH CHECK HEATER LINE. THE HOME PATIENT (HP) HAD NOT PROPERLY CONNECTED THE HEATER BAG AND IT DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE SUPPLIES WERE COMPROMISED AND THE HP WOULD NEED TO START OVER WITH NEW SUPPLIES. THE TSR WALKED THE HP THROUGH ENDING THERAPY AND ADVISED HIM TO CALL HIS REGISTERED NURSE WITHIN THE NEXT 24 HOURS REGARDING THE EVENT. PROPER PROCEDURES WERE REVIEWED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86649 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR HOMECHOICE