BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT-60

    MDR report key: 428706 · Received November 8, 2002

    Report

    Report Number
    1721649-2002-00001
    Event Type
    Malfunction
    Date Received
    November 8, 2002
    Date of Event
    December 15, 2000
    Report Date
    November 8, 2002
    Manufacturer
    SEPARATION TECHNOLOGY, INC.
    Product Code
    JQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SPINNING OF BLOOD SPECIMENS THE CENTRIFUGE "EXPLODED", MOTOR BROKE INTO 3 PARTS AND FLEW TK THROUGH LAB. BLOOD TUBES ALSO EXPLODED SENDING PT BLOOD THROUGHOUT LAB AREA. EMPLOYEE STRUCK BY FLYING MOTOR PART AND HAD BLOOD/BODY FLUID EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT-60 CENTRIFUGE JQC SEPARATION TECHNOLOGY, INC. STAT-60 21

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other