BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2852275 · Received November 30, 2012

    Report

    Report Number
    1416980-2012-06234
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 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. THE ROOT CAUSE WAS USE ERROR - OPEN CLAMP. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A SAMPLE EVALUATION WILL NOT BE CONDUCTED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE NO BATCH REVIEW COULD BE PERFORMED.

    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 HOME PATIENT (HP) CALLED IN NEEDING ASSISTANCE CLEARING A SE 2240 ALARM THAT NIGHT AT THE TIME OF THE CALL THE HP WAS STILL CONNECTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) FOUND THE HP HAD ONE SUPPLY LINE CLAMP LEFT OPEN CAUSING THE 2240 ALARM IN INITIAL DRAIN. THE TSR CLEARED THE ALARMS AND THE HP DISCONNECTED AND CAPPED OFF. THEY WOULD RESET UP AGAIN WITH NEW SUPPLIES. THE TSR REFERRED THE HP TO THE ON CALL NURSE FOR FURTHER MEDICAL INSTRUCTIONS. 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. 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 SUPPLY BAGS WERE PROPERLY CONNECTED. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. THE HOME CHOICE SET WAS NOT BEING REUSED. THE PATIENT DID NOT HAVE ANY PETS THAT CAUSED DAMAGE TO THE SUPPLIES. THERE WAS NO DAMAGE NOTED TO THE OVER POUCH OR CARTON IN WHICH THE CASSETTE WAS DELIVERED. A SHARP OBJECT WAS NOT USED TO ASSIST IN THE OPENING OF THE CARTON OR OVER POUCH. 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. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. 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 63 YR HOME CHOICE