BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 822408 · Received February 16, 2007

    Report

    Report Number
    1722028-2007-00001
    Event Type
    Other
    Date Received
    February 16, 2007
    Date of Event
    January 17, 2007
    Report Date
    February 14, 2007
    Manufacturer
    GAMBRO BCT, INC.
    Product Code
    LKN
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURERS INVESTIGATION INCLUDED RUN DATA ANALYSIS OF THE EVENT, SIMULATED TESTING, REVIEW OF HEALTH RISK AND A REVIEW OF LABELING. THE MANUFACTURERS INVESTIGATION CONCLUDED THE DEVICE PERFORMED TO SPECIFICATION.

    Description of Event or Problem · 1

    A DONOR WAS CONNECTED TO THE TUBING SET PRIOR TO THE TUBING SET BEING FULLY LOADED ONTO THE MACHINE. PRE-CONNECTING TESTS AND VERIFICATIONS HAD NOT BEEN PERFORMED AS INSTRUCTED BY THE MACHINE'S OPERATOR MANUAL. WHEN THE FACILITY'S OPERATOR REALIZED THE ERROR AND THE MACHINE WAS NOT READY TO START THE DONATION PROCEDURE, THE TUBING SET WAS CLAMPED AND THE DONOR WAS DISCONNECTED FROM THE TUBING SET. BECAUSE THE MACHINE HAD BEEN IN-PROCESS OF LOADING THE TUBING SET WHEN IT WAS STOPPED, THERE IS A POSSIBILITY THAT THE MACHINE WOULD NOT HAVE REACHED A COMPLETE AIR EVACUATION STATE. THIS COULD POTENTIALLY EXPOSE THE DONOR TO AIR BECAUSE THE DONOR WAS CONNECTED TO THE TUBING SET WHILE IN THIS STATE. THE DONOR EXPERIENCED MUSCLE SPASM IN HIS ARM UPON DISCONNECTING THE TUBING SET, CHEST PRESSURE AND SOME COUGHING. THERE WAS NO MEDICAL INTERVENTION AND THE DONOR IS REPORTED TO BE FINE. THERE WAS NO ALLEGED MACHINE MALFUNCTION WHICH WAS ALSO CONFIRMED THROUGH THE MANUFACTURER'S INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM AUTOMATED BLOOD COLLECTION SYSTEM LKN GAMBRO BCT, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other