BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINIFUGE

    MDR report key: 139362 · Received December 18, 1997

    Report

    Report Number
    8010672-1997-00001
    Event Type
    Other
    Date Received
    December 18, 1997
    Date of Event
    December 3, 1997
    Report Date
    December 12, 1997
    Manufacturer
    HERAEUS INSTRUMENTS GMBH
    Product Code
    JQC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CENTRIFUGE UNIT WAS OPERATING AT SPEED OF 3,500 REVOLUTIONS PER MINUTE. THE ROTOR NUT WAS NOT CHECKED PRIOR TO INITIATING THE RUN. THE ROTOR NUT RELEASED CAUSING BREAKAGE OF GLASS TUBES AND DAMAGE TO OTHER INTERNAL COMPONENTS OF UNIT. TWO SECURING SCREWS FOR THE RIGHT LID LOCK WERE MISSING FROM THE LID LOCK AND FOUND AT THE BASE OF THE CENTRIFUGE HOUSING. THE UNSECURED LID LOCK AND POSSIBLE OUT OF TOLERANCE LID DIMENSIONS ALLOWED ROTOR TO EJECT. FOUR BROKEN GLASS TUBES (TWO CONTAINING BLOOD SAMPLES AND TWO BALANCE TUBES) WERE RELEASED FROM UNIT TO ADJACENT AREA. GLASS FRAGMENTS AND BLOOD SPLATTER CAME IN CONTACT WITH THE OPERATORS FACIAL AREA. NO INJURIES OR EXTERNAL DAMAGE RESULTED FROM THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINIFUGE CENTRIFUGE JQC HERAEUS INSTRUMENTS GMBH 75003538 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other