BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2070097 · Received April 18, 2011

    Report

    Report Number
    2070097
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 18, 2011
    Manufacturer
    HETTICH INSTRUMENTS
    Product Code
    JQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    CENTRIFUGE #1 FOR PROCESSING PATIENT BLOOD SPECIMENS REPORTEDLY "CAME UNDONE" DURING USE, AT 4500 RPM, SENDING THE FRONT PANEL OF THE MODULE AND PIECES OF THE CENTRIFUGE FLYING, UP TO APPROXIMATELY 5 FEET FROM THE CENTRIFUGE. AT THE TIME, THERE WAS A LOUD BANG FOLLOWED BY A CONTINUOUS ROLLING AND CRASHING THAT LASTED FOR APPROXIMATELY 5-10 SECONDS. THERE WAS A HISSING SOUND AND A PUFF OF SMOKE AND AN ODD ODOR PRESENT. THERE WAS NO WARNING, NO OUT OF THE ORDINARY SOUNDS OR MOTIONS EMANATING FROM THE CENTRIFUGE PRIOR TO THIS EVENT. THERE WERE SEVEN (7) PATIENT SAMPLES IN THE CENTRIFUGE THAT COULD NOT BE RETRIEVED. THE MANUFACTURER HELPED IN FINDING THE IDENTIFICATION OF THOSE SAMPLES SO CARE PROVIDERS COULD BE NOTIFIED TO REDRAW AND RESEND BLOOD SPECIMENS. SIX (6) EMPLOYEES WERE SUBSEQUENTLY SEEN IN THE EMERGENCY DEPARTMENT OF THIS FACILITY REPORTEDLY RELATED TO EXPOSURE TO A LOUD NOISE, INHALATION OF AN UNIDENTIFIED SUBSTANCE AND POTENTIAL FOR BLOOD EXPOSURE AS THE CENTRIFUGE WAS PROCESSING PATIENT BLOOD SPECIMENS AT TIME OF FAILURE. DEPARTMENT OF SAFETY, DEPARTMENT OF SECURITY, AND THE MANUFACTURER WERE NOTIFIED AND RESPONDED. CENTRIFUGE #2 WAS ALSO SHUT DOWN, AS PRECAUTION, UNTIL ROTORS AND BUCKETS WERE REPLACED. CENTRIFUGE #2 IS EXPECTED TO BE OPERATIONAL BY TOMORROW AND CENTRIFUGE #1 IS TO BE REPLACED BY THE DAY AFTER. THE DAMAGED CENTRIFUGE HAS BEEN SENT TO THE COMPANY FOR ANALYSIS.====================== MANUFACTURER RESPONSE FOR CENTRIFUGE MALFUNCTION, (BRAND NOT PROVIDED)======================DID NOT RECEIVE ANYTHING IN WRITING AS TO THE CAUSE UNTIL THEY HAVE TIME TO INVESTIGATE AND ANALYZE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CENTRIFUGE MALFUNCTION JQC HETTICH INSTRUMENTS ROTANTA RSC ROBOTIC *

    Patients

    Seq Age Sex Outcome Treatment
    1 *