BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2851135 · Received November 29, 2012

    Report

    Report Number
    1416980-2012-06126
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 18, 2012
    Report Date
    November 18, 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 LEAK WAS NOT 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A LEAK WHICH OCCURRED ON THE HOMECHOICE (HC) DURING SET UP; THE PATIENT WAS NOT CONNECTED. THE CAREGIVER (CG) EXPLAINED THAT THE HC WAS ALREADY SET UP AND THAT THE HOME PATIENT (HP) HAD COME TO CONNECT AND START THERAPY AND FOUND THAT ONE OF THE SECONDARY BAGS HAD DISCONNECTED FROM THE SET UP AND WAS ON THE FLOOR INSTEAD. THERE WAS SOLUTION ON THE FLOOR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CG CLOSE ALL OF THE CLAMPS TO THE BAGS AND PATIENT LINE, CYCLE THE POWER, PRESS "GO" TO START, AND AT "LOAD THE SET", REMOVE THE CASSETTE. THE TSR ADVISED THE CG TO DISPOSE OF THE CURRENT SUPPLIES CONNECTED AND START OVER WITH ALL NEW SUPPLIES. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE CARE GIVER ON (B)(4) 2012. SHE STATED THAT SHE DID NOT NOTICE ANYTHING UNUSUAL ABOUT THE SUPPLIES THAT NIGHT. AFTER STARTING OVER WITH NEW SUPPLIES, THERAPY WENT WELL. THERE WERE NO SAMPLES AVAILABLE AND SHE DID NOT KNOW THE LOT NUMBER. THERAPY SINCE HAS BEEN GOING WELL, AND NO ADVERSE EFFECTS WERE 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 74 YR HOMECHOICE