BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2771053 · Received October 3, 2012

    Report

    Report Number
    1416980-2012-01498
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 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). THE PROBLEM WAS CONFIRMED; PER THE COMPLAINT INFORMATION THE MOST LIKELY ROOT CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE SUPPLY BAG DISCONNECTED. THE ROOT CAUSE WAS SUPPLY BAG DISCONNECTED WITHOUT FALLING. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING INITIAL DRAIN. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CYCLE THE POWER ON THE HC. A SE 2367 ALARMED ON THE HC. THE TSR HAD THE HP CYCLE POWER ON THE HC AGAIN. THE TSR EXPLAINED BOTH SYSTEM ERRORS ON THE HC TO THE HP AND THE HP UNDERSTOOD. THE TSR ADVISED THE HP WOULD NEED TO START OVER WITH ALL NEW SUPPLIES. THE HP UNDERSTOOD AND SAID HE HOOKED UP THE ONE OF THE BAGS INCORRECTLY. THE HP WOULD START OVER WITH ALL NEW DISPOSABLES. THE PATIENT WAS CONNECTED EITHER AT THE TIME OF THE ALARM OR OBSERVED AIR. THE PATIENT LINE WAS PROPERLY PRIMED BEFORE CONNECTING. PATIENT EXTENSION LINES WERE NOT USED. THEY WERE NOT CONNECTED TO PRIMING. THE PATIENT LINE DID NOT BECOME SEPARATED FROM THE TRANSFER SET. THE PATIENT DID NOT PRESS GO TO START THERAPY BEFORE CONNECTING. A DUMMY TUMMY WAS NOT BEING USED. THE PATIENT DID NOT DISCONNECT ANY TIME PRIOR TO THE ALARM OR OBSERVED AIR. ALL BAGS WERE NOT PROPERLY CONNECTED. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE REPORTER. THE SUPPLIES WERE NOT DAMAGED BY AN OUTLET PORT CLAMP OR AN ASSIST DEVICE USED TO MAKE THE CONNECTIONS. THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE HC WAS OPERATIONAL AND THE CALL COMPLETED. 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 84 YR HOMECHOICE