BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2931906 · Received January 28, 2013

    Report

    Report Number
    1416980-2013-02092
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 6, 2013
    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 UNDETERMINED. PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL RELEVANT 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 DRAIN 3 OF 5. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HELPED THE HOME PATIENT (HP) TO CLEAR THE ERROR AND INFORMED HER OF THE ERROR'S MEANING. PER THE HP SHE DISCONNECTED SOMETIME LAST NIGHT. THERE WAS A LOOSE CONNECTION. 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. PROPER DISCONNECT PROCEDURES WERE NOT USED. THE PATIENT DID NOT RECONNECT. THE HP WOULD COMPLETE THERAPY WITH MANUAL SUPPLIES. 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
    37869 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR HOME CHOICE