BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3241321 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19337
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 30, 2013
    Report Date
    June 30, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TROUBLESHOOTING FOR AN UNRELATED ALARM ON THE HOMECHOICE (HC) DEVICE, THE HOME PATIENT (HP) SAW A COUPLE OF BUBBLES IN THE PATIENT LINE DURING THE INITIAL DRAIN. THE HP WAS CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP IN ENDING THERAPY. THE HP WAS GOING TO PERFORM A MANUAL EXCHANGE IN THE MORNING. DURING THE FOLLOW UP, THE HP ALSO STATED THAT THEY DID NOT DISCONNECT ANY TIME PRIOR TO SEEING THE AIR IN THE LINE. THE HP EXPLAINED THAT THE PATIENT LINE WAS PRIMED, ALL OF THE BAGS WERE PROPERLY CONNECTED AND THEY SAW NOTHING UNUSUAL ABOUT THE SUPPLIES. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340594 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR HOMECHOICE