BEUDAMED
    FDA Adverse Event Summary report: N

    BODYGUARD

    MDR report key: 4253181 · Received September 24, 2014

    Report

    Report Number
    4253181
    Date Received
    September 24, 2014
    Date of Event
    June 14, 2014
    Report Date
    September 11, 2014
    Manufacturer
    CME AMERICA, LLC
    Product Code
    FRN
    Report Source
    User Facility report
    Reporter Location
    LA, US

    Narratives

    Description of Event or Problem · 1

    THE BRAUN IPX3 PCA PUMPS ARE: 1) SET UP TO BE USED IN ONE WAY ONLY, THAT IS USING A SMALL IV BAG; 2) THE PUMP CAN BE CONFIGURED WITH DIFFERENT PASSCODE REQUIREMENTS IN ORDER TO MAKE CHANGES (ALL, NONE, OR SOME); 3) THE LOCKABLE CASE HAS AN ACCESS WINDOW FOR THE KEYPAD: 4) THE PRIMING VOLUME IS NOT AUTOMATICALLY SUBTRACTED FROM THE STARTING VOLUME; AND 5) ONLY ONE TUBING SET WILL ALLOW THE USE OF PIGGY BACK INFUSION.WHEN "ALL" CODES ARE SET, THE NURSE MUST ENTER THE PASSCODE SEVEN (7) TIMES TO START AN INFUSION.THIS FACILITY HAD ELECTED TO USE SYRINGES, RATHER THAN BAGS, TO BETTER TRACK NARCOTIC USAGE. THE PLASTIC CASE HAD TO BE MODIFIED TO ACCOMMODATE THIS. IN ORDER TO REDUCE THE NUMBER PASSCODES REQUIRED A PLEXIGLASS COVER WAS INSTALLED OVER THE OPENING IN THE CASE.IF THE BEGINNING VOLUME IS NOT MANUALLY CORRECTED AFTER PRIMING, SUBSEQUENT INFUSED VOLUMES WILL NOT CORRESPOND WITH THE SYRINGE VOLUME.======================MANUFACTURER RESPONSE FOR PCA PUMP, CME COLOR VISION (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593176 BODYGUARD PUMP, INFUSION FRN CME AMERICA, LLC 575 COLORVISION *

    Patients

    Seq Age Sex Outcome Treatment
    1 *