BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2834090 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05274
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 3, 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 REPORT OF A SYSTEM ERROR 2240 WAS CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. 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 PRIOR TO CONNECTION AND THERE WERE NO PATIENT EXTENSION LINES IN USE. THE PATIENT HAD NOT DISCONNECTED PRIOR TO THE ALARM. THERE WERE NO OPEN CLAMPS ON UNUSED LINES. THE CARE GIVER (CG) STATED THAT THE CONNECTION TO ONE OF THE SUPPLY BAGS WAS LOOSE, THAT THE BAG DISCONNECTED FROM LINE, AND THEN THE ALARM OCCURED. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES, AND THEY HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR AN ASSIST DEVICE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CG POWER CYCLE THE HC TO END THERAPY AND ADVISED THE CG TO START OVER WITH NEW SUPPLIES. THE TSR ADVISED THE CG TO CALL THE PATIENT'S REGISTERED NURSE ABOUT THE POSSIBLE EXPOSURE TO UNSTERILE AIR. PROPER PROCEDURES WERE REVIEWED WITH THE CG. THE LOT NUMBER AND SAMPLES WERE UNAVAILABLE. THE HC WAS OPERATIONAL. 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
    1 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