BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HETTICH CENTRIFUGE

    MDR report key: 3952396 · Received May 13, 2014

    Report

    Report Number
    1119779-2014-00011
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 18, 2014
    Manufacturer
    ANDREAS HETTICH GMBH & CO. KG
    Product Code
    GKG
    PMA / PMN Number
    P970018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BD NOTED THE RETURNED CENTRIFUGE SHOWED SIGNS OF HAVING AN ELECTRICAL ISSUE ON THE OUTSIDE OF THE INSTRUMENT AROUND THE PLUG AREA THAT WAS NOT ORIGINALLY REPORTED BY THE CUSTOMER. THE INSTRUMENT WAS CHARRED ON THE BACK AND HAD A MELTED PLUG RECEPTACLE. THE INSIDE OF THE CENTRIFUGE DID NOT SHOW ANY SIGNS OF BURNING OR DAMAGE. THE PLUG RECEPTACLE WITH SUPPRESSION FILTER FUNCTIONED AS DESIGNED AND PROTECTED THE INTERNAL ELECTRONICS OF THE CENTRIFUGE. THE PLUG GOT HOT ENOUGH TO MELT INSIDE OF THE RECEPTACLE ON THE CENTRIFUGE. QUALITY DETERMINED DURING THE INVESTIGATION THAT THE CENTRIFUGE WAS BEING RUN AT THE CUSTOMER SITE WITHOUT THE MOTOR COVER IN PLACE, WHICH ALLOWED FLUID TO GET INSIDE OF THE MOTOR FROM THE TOP. THIS IS BELIEVED TO BE THE ROOT CAUSE OF THE FAILURE. IT IS UNKNOWN WHY THE COVER WAS REMOVED. THE CENTRIFUGE VENDOR WAS CONTACTED FOR FURTHER INFORMATION AND CONFIRMED THEY HAVE NO TRENDS ON THIS TYPE OF FAILURE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON (B)(6) 2014 THAT HETTICH 380 CENTRIFUGE STOPPED WORKING. THE UNIT WAS RETURNED TO BD FOR INVESTIGATION. DURING INVESTIGATION ON (B)(6) 2014, IT WAS NOTED THAT THE INSTRUMENT WAS CHARRED ON THE BACK AND HAD A MELTED PLUG RECEPTACLE. TECHNICAL SERVICE CONTACTED THE CUSTOMER FOR FURTHER DETAILS. THE CUSTOMER STATED THAT AFTER THE CENTRIFUGE STARTED IT'S SECOND SPIN THERE WAS A SPARK AND SMOKE BUT NO FIRE. THEY UNPLUGGED THE UNIT AND CONTACTED THEIR MAINTENANCE DEPARTMENT TO CHECK THE OUTLETS IN THE LAB. NO ISSUES WERE FOUND AND CUSTOMER STATED IT WAS PLUGGED INTO THE CORRECT VOLT OUTLET. NO INJURIES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285663 HETTICH CENTRIFUGE GKG ANDREAS HETTICH GMBH & CO. KG 1701-30

    Patients

    Seq Age Sex Outcome Treatment
    1