BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTI® J20I CENTRIFUGE

    MDR report key: 2471749 · Received February 28, 2012

    Report

    Report Number
    2050012-2012-00613
    Event Type
    Injury
    Date Received
    February 28, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 2, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQC
    PMA / PMN Number
    CLASS1EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012 TO INSPECT THE INCIDENT. THE FSE CONFIRMED THAT THE CANISTERS HAVE A SERVICE LIFE OF 7 YEARS. THE CANISTERS MAY HAVE BEEN BEYOND THE SERVICE LIFE SINCE THE ROTOR (BASED ON THE SERIAL NUMBER OF THE INSTRUMENT) IS APPROXIMATELY 12 YEARS OLD. THE FSE REQUESTED THAT THE ROTOR AND CANISTERS BE RETURNED TO BEC TO VERIFY THE PRELIMINARY FINDINGS. AS OF (B)(6) 2012, THE OPERATOR WAS NO LONGER HAVING TINNITUS AND WAS BACK AT WORK. THE BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE OPERATOR HEARD A LOUD BANGING SOUND COMING FROM THE AVANTI J20I CENTRIFUGE IMMEDIATELY AFTER THE JLA-10.500 ROTOR ACCELERATED TO 10,000 RPM. BASED ON THE PRELIMINARY INVESTIGATION OF THE UNIT, THE LOUD BANGING SOUND ROOTED FROM A CANISTER FAILURE. IT WAS CONFIRMED THAT THE ROTOR DID NOT FAIL AND WAS FULLY LOADED WITH SIX BOTTLES AT THE TIME OF THE INCIDENT. THE SPINDLE AND ROTOR INSIDE THE UNIT WAS COMPLETELY DEMOLISHED AND THE ROTOR CHAMBER WAS PHYSICALLY COMPROMISED WITH "BUMPS." THE CUSTOMER EXPERIENCED RINGING IN THE EARS (TINNITUS) DUE TO THE LOUD BANGING SOUND AND NEEDED TO SEEK MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTI® J20I CENTRIFUGE CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE JQC BECKMAN COULTER INC. AVANTI® J20I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other