BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2935840 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02312
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 14, 2013
    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 REPORT OF A SYSTEM ERROR 2240 WAS CONFIRMED. THE ROOT CAUSE WAS LOOSE CONNECTION. THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 1 OF 4. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT LINE HAD BEEN PROPERLY PRIMED AND THERE WERE NO PATIENT EXTENSIONS IN USE. THE PATIENT DID NOT DISCONNECT PRIOR TO THE ALARM. THERE WERE NO OPEN CLAMPS ON UNUSED LINES. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES AND THEY HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. ONE OF THE SUPPLY BAGS WAS NOT FULLY CONNECTED, AND THE SETUP WAS LEAKING FROM THE CONNECTION POINT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CYCLE THE POWER ON THE HC TO END THERAPY AND ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THE TSR ADVISED THE HP TO CONTACT HIS REGISTERED NURSE ABOUT THE POSSIBLE EXPOSURE TO UNSTERILE AIR. THE HP AS ENDING THERAPY FOR THE NIGHT. THE HC WAS OPERATIONAL. PROPER PROCEDURES WERE REVIEWED. THERE WERE NO SAMPLES OR LOT NUMBERS AVAILABLE. 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
    41415 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR HOMECHOICE