BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3142434 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14067
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE; THEREFORE, NO DEVICE ANALYSIS COULD BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) HAD RECEIVED A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE), WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 2 OF 5. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. THE TSR ASSISTED THE REGISTERED NURSE (RN) WITH THE TROUBLESHOOTING AND THE RN CYCLED THE POWER ON THE MACHINE TO CLEAR THE ALARM. THE RN STATED THAT THEY WOULD RESET UP THE MACHINE WITH ALL NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244958 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR HOMECHOICE