BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTI J-30I CENTRIFUGE

    MDR report key: 1067684 · Received June 30, 2008

    Report

    Report Number
    2912312-2008-00001
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 30, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE INSPECTED THE DEVICE AND DETERMINED THAT THE ROTOR PINS HAD BEEN EXTENSIVELY DAMAGED IN A PRIOR RUN AND A COMBINATION OF WORN HUB PINS ALLOWED THE ROTOR BEING TO SPIN FREELY ON THE HUB. THE NOISE THE CUSTOMER HEARD WAS THE ROTOR BEING FREE ON THE HUB DUE TO THE LACK OF PIN CONTACT. NORMALLY, THE LID TIE DOWN SCREW ALSO ATTACHES THE ROTOR TO THE DRIVE HUB. AS THE ROTOR WAS NOT TIED DOWN PROPERLY, IT WOULD TEND TO LEVITATE SLIGHTLY WHILE RUNNING AND LOOSE CONTACT WITH THE DRIVE HUB PINS. AS PER FSE, IMPROPER ROTOR TIE DOWN WOULD USUALLY CREATE SOME NOISE DURING ACCELERATION AND TYPICALLY LEAD TO AN INSTRUMENT DIAGNOSTIC AND SHUT DOWN. IN THIS CASE, THE CUSTOMER STOPPED THE RUN MANUALLY BEFORE ANY DIAGNOSTIC WAS GIVEN. ADDITIONALLY, IF THE ROTOR WAS NOT ENGAGED WITH THE DRIVE HUB, IT MAY NOT HAVE BEEN TURNING AT THE SAME SPEED AS THE SHAFT AND HAD COME TO A COMPLETE STOP WHEN THE SHAFT DID. HARDWARE ISSUES MAY HAVE CONTRIBUTED TO THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN INCIDENT WITH THE AVANTI J-30I CENTRIFUGE. PER CUSTOMER, THEY RUN A CENTRIFUGE AND WHEN THE RPM INDICATED ZERO AND INSTRUMENT WAS BEEPING, THE CUSTOMER OPENED THE DOOR AND FOUND THE ROTOR STILL SPINNING. THE OPERATOR GRABBED THE ROTOR LID AND REMOVED IT THEN ATTEMPTED TO STOP THE ROTOR BY HAND. AS A RESULT OF THIS ACTION, THE OPERATOR HAD INJURED HER HAND. THE INJURY REQUIRED 4 STITCHES ON A FINGER. THE INSTRUMENT IS NOT USED IN IVD APPLICATIONS. THEREFORE, THERE IS NO CLINICAL IMPACT SINCE THIS INSTRUMENT DOES NOT PRODUCE PT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTI J-30I CENTRIFUGE LABORATORY CENTRIFUGE FOR SAMPLE PREPARATION JQC BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other