BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRA

    MDR report key: 5103745 · Received September 25, 2015

    Report

    Report Number
    5103745
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Date of Event
    September 11, 2015
    Report Date
    September 11, 2015
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE LID ON THE CENTRIFUGE SLAMS SHUT BECAUSE THE GAS DAMPER/HYDRAULIC SPRING. WE STARTED USING THIS DEVICE IN (B)(6) 2012 AND IT WORKED WELL UNTIL (B)(6) 2015 WHEN WE FIRST REPLACED THIS DAMPER, FAILED AND REPLACED AGAIN IN (B)(6) 2015, THEN AGAIN (B)(6) 2015 AND NOW IN (B)(6) IT FAILED AGAIN. MANUFACTURER RESPONSE FOR CENTRIFUGE, BECKMAN (PER SITE REPORTER): SINCE THE FAILURE WAS SO QUICK THEY REPLACED THE PART UNDER WARRANTY, BUT SINCE THIS IS THE FOURTH TIME THAT THIS HAS HAPPENED IN 7 MONTHS WE HAVE ASKED THEM TO COME OUT TO EVALUATE IT INSTEAD OF US JUST REPLACING THE PART. WE ARE CURRENTLY WAITING FOR AN ETA FROM THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634494 ALLEGRA CENTRIFUGE JQC BECKMAN COULTER, INC. X-30

    Patients

    Seq Age Sex Outcome Treatment
    1