BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT 60

    MDR report key: 133728 · Received November 21, 1997

    Report

    Report Number
    MW1012516
    Event Type
    Malfunction
    Date Received
    November 21, 1997
    Date of Event
    October 6, 1997
    Report Date
    November 18, 1997
    Manufacturer
    SEPARATION TECHNOLOGY
    Product Code
    GHK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING CENTRIFUGATION OF COAG SPECIMEN, CORK CAME OUT OF TUBE WHICH FORCED THE LID TO POP OPEN. CORK FLEW OUT OF CENTRIFUGE. THIS IS THE SECOND TIME THIS HAS HAPPENED. FIRST OCCURRENCE 10/6/97. UNIT RETURNED TO CO & COULDN'T BE REPRODUCED. UNIT HAS BEEN SENT BACK A SECOND TIME NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT 60 CENTRIFUGE GHK SEPARATION TECHNOLOGY STAT 60 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other