BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE

    MDR report key: 2133158 · Received June 19, 2011

    Report

    Report Number
    1423500-2011-07804
    Event Type
    Malfunction
    Date Received
    June 19, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE, THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW WILL NOT BE PERFORMED. A 510K NUMBER CANNOT BE PROVIDED IN THIS REPORT BECAUSE THE PRODUCT CODE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A DOCTOR REPORTED TO BAXTER (B)(4) THAT THE BAG DOES NOT CONNECT TO THE SET IN A GOOD WAY. THE CONNECTION TURNS WITHOUT CLOSING AND THEN THERE IS A DISCONNECTION. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1