BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1802310 · Received August 17, 2010

    Report

    Report Number
    1423500-2010-02476
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 13, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BAXTER (B)(4) SPOKE WITH THE PATIENT'S DAUGHTER ON (B)(6) 2010. THE DAUGHTER STATED THE PATIENT WAS HAVING ISSUES WITH "BUBBLES IN THE TUBING." THE SAMPLES WERE DISPOSED OF AND THE LOT NUMBER WAS UNKNOWN. THE PATIENT WAS ADVISED TO SAVE A CASSETTE THE NEXT TIME THE ISSUE OCCURS. THE PATIENT USUALLY MASSAGES THE LINES AND THERAPY CONTINUES AND IF THAT DOESN'T WORK NEW SUPPLIES ARE USED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR