BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2910441 · Received January 11, 2013

    Report

    Report Number
    1416980-2013-00862
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 28, 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 2240 (AIR IN SET) IS CONFIRMED BECAUSE THE PATIENT REPORTED DISCONNECTING FROM THE TRANSFER SET DURING THERAPY, WHICH IS USE ERROR THAT CAN CAUSE SYSTEM ERROR 2240 ALARMS. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WAS NOT CONDUCTED. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240 (AIR IN SET) DURING DWELL 2 ON THE HOME CHOICE (HC). THE HOME PATIENT (HP) STATED HE DISCONNECTED AND RECONNECTED. THE HP STATED HE PRESSED STOP BUT WASN'T SURE HE CLOSED ALL THE CLAMPS. THE HP ALSO STATED HE RECONNECTED BUT WASN'T SURE IF HE DID THAT PRIOR TO PRESSING GO. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INFORMED THE HP THAT AIR WAS INGESTED INTO THE SYSTEM AND HE WOULD NEED TO END THE THERAPY. THE HP STATED HE WOULD WAIT TO START ANOTHER THERAPY THE FOLLOWING DAY. THE TSR ASSISTED THE HP TO END THE THERAPY AND DISCONNECT. THE TSR ADVISED THE HP TO DISPOSE OF ALL THE CURRENT SUPPLIES USED. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18045 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR HOMECHOICE