BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD 323 INFUSION PUMP

    MDR report key: 6114564 · Received November 18, 2016

    Report

    Report Number
    3006967710-2016-00011
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Report Date
    October 21, 2016
    Manufacturer
    CME AMERICA, LLC
    Product Code
    FRN
    PMA / PMN Number
    K042696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT AN OVER-INFUSION OCCURRED BECAUSE THE PUMP WAS PROGRAMMED IN ERROR TO DELIVER THE ENTIRE BAG VOLUME IN 1 HOUR, INSTEAD OF 48 HOURS. PATIENT HAS BEEN USING THE SAME PUMP FOR CHEMOTHERAPY EVERY 3 WEEKS, SUCCESSFULLY SINCE (B)(6) 2015. THE MEDICATION INFUSED WAS 5-FU WITH AN INTENDED INFUSION OF 641 ML AT 13.3 ML/HR, BUT WAS MISTAKENLY ENTERED AS 641 ML AT A RATE OF 641 ML/HR. THIS WAS CONFIRMED THROUGH THE DEVICES' ON-BOARD EVENT LOG, AS WELL AS SEVERAL PRIOR INFUSIONS THAT WERE ENTERED CORRECTLY AND WERE COMPLETED SUCCESSFULLY. THE CUSTOMER CONFIRMED THERE WAS NO HARM TO THE PATIENT. CME AMERICA INSPECTED THE COMPLAINT DEVICE, THE PUMP HAS MET ALL SPECIFICATIONS AND PASSED ALL VOLUME TESTING. THE INSTRUCTIONS FOR USE (IFU) WERE ALSO REVIEWED AND FOUND TO BE ADEQUATE. THE USER HAD MISTAKENLY PROGRAMMED THE VOLUME TO BE INFUSED (VTBI) AS THE RATE. THIS OVER-INFUSION WAS CAUSED BY THE USER MIS-PROGRAMMING THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED CME AMERICA TO REQUEST A PRINTOUT OF THE HISTORY LOG FOR THIS DEVICE, TO CONFIRM A PROGRAMMING ERROR THAT LED TO AN OVER-INFUSION. THE CUSTOMER REPORTED THAT THE OVER-INFUSION OCCURRED BECAUSE THE PUMP WAS PROGRAMMED IN ERROR TO DELIVER THE ENTIRE BAG VOLUME IN 1 HOUR, INSTEAD OF 48 HOURS. THE INTENDED INFUSION OF 641 ML AT 13.3 ML/HR WAS MISTAKENLY ENTERED AS 641 ML AT A RATE OF 641 ML/HR. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763948 BODYGUARD 323 INFUSION PUMP BODYGUARD 323 PUMP FRN CME AMERICA, LLC 100-603XSA

    Patients

    Seq Age Sex Outcome Treatment
    1