BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2771019 · Received October 3, 2012

    Report

    Report Number
    1416980-2012-01496
    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). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) IS CONFIRMED BECAUSE THE PATIENT REPORTED HAVING A CLAMP OPEN ON AN UNUSED SUPPLY LINE DURING THERAPY, WHICH IS A USE ERROR THAT CAN CAUSE SYSTEM ERROR 2240 ALARMS. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) DETERMINED THE HOME PATIENT (HP) HAD TWO UNUSED LINES OPEN IN THE ORGANIZER DURING PRIME. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    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 PRIME. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) DETERMINED THE HOME PATIENT (HP) HAD TWO UNUSED LINES OPEN IN THE ORGANIZER DURING PRIME. THE TSR ASSISTED THE HP TO END THERAPY AND DISPOSE OF ALL CURRENT SUPPLIES AND START OVER WITH ALL NEW SUPPLIES. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED DURING BAXTER'S INVESTIGATION. THE PATIENT WAS CONNECTED EITHER AT THE TIME OF THE ALARM OR OBSERVED AIR. THE PATIENT LINE WAS NOT PROPERLY PRIMED BEFORE CONNECTING. 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. THE PATIENT DID NOT RECONNECT. ALL BAGS WERE PROPERLY CONNECTED. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. THE SUPPLIES WERE NOT DAMAGED BY AN OUTLET PORT CLAMP OR AN ASSIST DEVICE USED TO MAKE THE CONNECTIONS. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE REPORTER. 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 83 YR HOME CHOICE