BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMO FISHER SCIENTIFIC

    MDR report key: 1216534 · Received October 30, 2008

    Report

    Report Number
    MW5008817
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 24, 2008
    Manufacturer
    THERMO FISHER SCIENTIFIC, HEADQUARTERS
    Product Code
    KSE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    RECURRING PROBLEMS WITH BLOOD BANK REFRIGERATOR DOOR HANDLES. DOOR HANDLES (LOCK & STRIKE ASSEMBLY) ARE HAVING TO BE REPLACED ON A QUARTERLY BASIS. THE DOOR HANDLES APPEAR TO BE OF POOR DESIGN AND MADE WITH INFERIOR MATERIALS THAT LEAD TO THEIR CONSTANT BREAKAGE. PRIOR TO THEIR COMPLETE FAILURE, THE HANDLES ALSO CAUSE PROBLEMS WITH THE CLOSURE OF THE REFRIGERATORS' DOORS. WHEN THIS OCCURS, THE REFRIGERATORS EXHIBIT INCREASED STORAGE TEMPS AND TEMP ALARMS RELATED TO THE DOOR NOT CLOSING PROPERLY AND SEALING, AND LEAD POTENTIALLY TO THE LOSS OF BLOOD PRODUCTS BY WAY OF THE INCREASED (EXCESSIVE) STORAGE TEMPS. WE FEEL THAT IF THE DOOR HANDLE WAS OF BETTER DESIGN AND MADE OF BETTER (E.G., STRONGER, MORE DURABLE) MATERIALS, THIS PROBLEMS WOULD NOT OCCUR AS OFTEN AS IT IS NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMO FISHER SCIENTIFIC BLOOD BANK REFRIGERATOR KSE THERMO FISHER SCIENTIFIC, HEADQUARTERS BPL25
    2 THERMO FISHER SCIENTIFIC BLOOD BANK REFRIGERATOR KSE THERMO FISHER SCIENTIFIC, HEADQUARTERS BBR25
    3 THERMO FISHER SCIENTIFIC BLOOD BANK REFRIGERATOR KSE THERMO FISHER SCIENTIFIC, HEADQUARTERS BBR55

    Patients

    Seq Age Sex Outcome Treatment
    1 Other