BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSPIN MP

    MDR report key: 3902117 · Received May 6, 2014

    Report

    Report Number
    2023446-2014-00050
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    GKG
    PMA / PMN Number
    K920759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STATSPIN CENTRIFUGE ROTOR BREAKAGE DURING OPERATION CAUSED FELINE BLOOD PRODUCTS/FLUIDS SPILLAGE; UN-CONTAINED OUTSIDE OF CENTRIFUGE. THE LID OF CENTRIFUGE BROKE-OFF AT THE HINGE. CUSTOMER REPORTED THAT THE CENTRIFUGE DRIVE WAS STILL SPINNING UNTIL IT WAS UNPLUGGED. NO INJURIES REPORTED INCLUDING DURING CLEAN-UP. A RING OF BLOOD EXISTS IN THE BOWL OF THE CENTRIFUGE, THAT THERE WAS BLOOD AND DEBRIS ON THE BENCH. THE FELINE SAMPLE WAS FROM AN ANIMAL THAT DID NOT HAVE ANY DISEASE INFECTIONS OF EITHER ANIMALS, OR HUMANS, AND DID NOT HAVE ANY DISEASE REPORTABLE TO THE FDA OR USDA. CUSTOMER DID NOT KNOW WHEN ROTOR RT12 WAS LAST REPLACED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ROTOR FAILURE LEADING TO BREAKAGE OF INTERNAL PARTS DURING OPERATION CAUSING SPILLAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271598 STATSPIN MP STATSPIN CENTRIFUGE GKG IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1