BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIKRO 120

    MDR report key: 2481677 · Received June 21, 2011

    Report

    Report Number
    3005990076-2011-00009
    Event Type
    Other
    Date Received
    June 21, 2011
    Date of Event
    May 3, 2011
    Report Date
    June 21, 2011
    Manufacturer
    A. HETTICH GMBH & CO. KG
    Product Code
    GHK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    ROTOR NOT CORRECTLY FASTENED TO MOTOR SHAFT. WHETHER THE USER DIDN'T FASTEN THE SCREW CORRECTLY OR WHETHER THE SCREW CAME LOOSE IN SPITE OF CORRECT FASTENING CANNOT BE RECONSTRUCTED. AFTER COMING OFF THE ROTOR THE SCREW DAMAGED THE PLASTIC LID LATCH OF THE CENTRIFUGE LID. THUS THE LID OPENED AND THE SCREW WAS THROWN OUT OF THE CENTRIFUGE. CENTRIFUGES OF THAT TYPE ARE NOT PRODUCED ANYMORE. THEY HAVE BEEN REPLACED BY AN IMPROVED VERSION. WITH THIS IMPROVED VERSION ALL CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED. ACTUALLY THERE IS A RECALL ACTION TAKING PLACE. WITH THE HELP OF EXCHANGE SETS WHICH CONVERTS THESE CENTRIFUGES INTO IMPROVED VERSIONS POORLY DESIGNED VERSIONS STILL PRESENT IN THE FIELD WILL BE ELIMINATED. FOR REASONS NOT KNOWN BY US THIS CENTRIFUGE WAS NOT YET SUBJECT TO OUR RECALL ACTION. SIMILAR CASE ALREADY REPORTED TO FDA. (B)(4).

    Description of Event or Problem · 1

    THE EVENT HAPPENED WITH A MICROLITER CENTRIFUGE. DURING THE RUN THE SCREW HOLDING THE ROTOR CAME LOOSE. THE SCREW THEN DESTROYED THE CLOSURE OF THE CENTRIFUGE LID LEFT THE CENTRIFUGE AND HIT THE WALL. NO ONE WAS HURT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIKRO 120 CENTRIFUGE MICROSEDIMENTATION GHK A. HETTICH GMBH & CO. KG 1204 (CENTRIFUGE)

    Patients

    Seq Age Sex Outcome Treatment
    1