BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWER PROCESSOR

    MDR report key: 1120645 · Received August 14, 2008

    Report

    Report Number
    2050012-2008-00035
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    July 3, 2008
    Report Date
    August 14, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    CLASS I
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OPERATOR DID NOT ATTEMPT TO PRESS THE EMERGENCY STOP, STATING THAT SHE WAS UNAWARE OF THE EMERGENCY STOP BUTTON. NO OTHER ADDITIONAL INFO IS AVAILABLE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN INCIDENT THAT OCCURRED ON THE POWER PROCESSOR. AN OPERATOR IN THE CUSTOMER LAB ATTEMPTED TO CLEAR A POWER PROCESSOR ALARM. THIS ALARM WAS CAUSED FROM A TUBE BEING TOO HIGH AND GETTING CAUGHT ON THE ARCH ENTERING THE SECONDARY DECAPPER. OPERATOR REACHED HAND INTO THE SECONDARY DECAPPER TO PUSH DOWN THE TUBE WITHOUT PAUSING IT. THE POWER PROCESSOR IFU CONTAINS THE FOLLOWING INSTRUCTIONS: "BEFORE PERFORMING AN ERROR RECOVERY PROCEDURE, MAKE SURE THAT THE PAUSE BUTTON IS LIT ON THAT MODULE." WHEN THE TUBE FREED, THE SECONDARY DECAPPER SLAMMED DOWN BEFORE THE HAND COULD BE REMOVED, IT KEPT PRESSURE ON THE HAND UNTIL IT ALARMED. IMMEDIATE MEDICAL ATTENTION WAS RECEIVED. SEVERAL X-RAYS HAVE BEEN TAKEN AND THE DOCTORS HAVE BEEN UNABLE TO DETERMINE IF THE HAND IS BROKEN. THE LAB FOLLOWED THEIR PROTOCOL AND FILLED OUT AN INCIDENT REPORT. CUSTOMER INJURY OCCURRED DUE TO NOT FOLLOWING PRODUCT INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER PROCESSOR CLINICAL AUTOMATION JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA