BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2833322 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05214
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) IS CONFIRMED; THE HP STATED THAT THE SUPPLY BAG APPEARS TO HAVE BEEN CONNECTED IMPROPERLY OR HAD COME LOOSE AND THERE WAS AIR IN THE SUPPLY LINE. NEITHER THE DISPOSABLE SET NOR THE HOMECHOICE MACHINE WERE RETURNED FOR EVALUATION AND THE USER DID NOT VERBALLY PROVIDE SUFFICIENT INFORMATION TO IDENTIFY THE CAUSE OF THE ALARM. THE ROOT CAUSE IS UNDETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE, NO BATCH REVIEW WAS PERFORMED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240/2367 (AIR IN LINE) DURING PRIME ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HOME PATIENT (HP) TO CYCLE THE POWER ON THE HC. THE HC ALARMED SYSTEM ERROR 2367. THE TSR INSTRUCTED THE HP TO CYCLE THE HC AGAIN AND THE HC PROCEEDED TO PRESS GO TO START. THE HP STATED THAT THE SUPPLY BAG APPEARS TO HAVE BEEN CONNECTED IMPROPERLY OR HAD COME LOOSE AND THERE WAS AIR IN THE SUPPLY LINE. THE TSR INFORMED THE HP THAT SHE WOULD HAVE TO START OVER USING ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR HOMECHOICE