BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1792064 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02341
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 17, 2010
    Report Date
    July 17, 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). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S (B)(4) AND REPORTED SOLUTION CAME OUT OF THE PATIENT LINE DURING THE PRIME CYCLE. THE HOME PATIENT (HP) HAD PREVIOUSLY CYCLED THE POWER TO GO THROUGH THE SET-UP AGAIN. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE HP IF SHE LEFT THE CLAMPS OPEN WHEN SHE CYCLED THE POWER. THE HP STATED YES. THE TSR EXPLAINED THAT IF THE CLAMPS WERE OPEN WHEN SHE PRESSED 'GO' TO LOAD THE SET, THAT THE SOLUTION WOULD MOVE FREELY AND WOULD COME OUT THE PATIENT LINE. THE HP STARTED OVER WITH NEW SUPPLIES. THE SAMPLE WAS DISCARDED AND LOT NUMBER WAS UNKNOWN. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR