BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2990210 · Received March 5, 2013

    Report

    Report Number
    1416980-2013-05288
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). . THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) IS CONFIRMED BECAUSE IT WAS REPORTED THAT HEATER BAG WAS NOT CONNECTED SECURELY AND BECAME DISCONNECTED DURING THERAPY, LINE DISCONNECTION IS A KNOWN CAUSE OF SE 2240. PER BAXTER LABELING, USERS ARE INSTRUCTED TO BE SURE THE LINES ARE CONNECTED SECURELY. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WAS NOT CONDUCTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 (AIR IN TUBING) DURING FILL 3 OF 4 ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HOME PATIENT (HP) TO CYCLE POWER. THE HP STATED THAT THE HEATER BAG WAS NOT CONNECTED SECURELY AND BECAME DISCONNECTED. THE HC ALARMED SYSTEM ERROR 2367. THE TSR HAD THE HP CYCLE POWER AND EXPLAINED THAT SHE WOULD HAVE TO SETUP WITH ALL NEW SUPPLIES OR SHE CAN PERFORM MANUAL THERAPY TO FINISH. THE HP STATED THAT SHE WOULD DISCONTINUE FOR THE NIGHT AND CONTACT HER REGISTERED NURSE (RN) IN THE MORNING. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93691 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR HOMECHOICE