BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD 575 COLORVISION INFUSION PUMP

    MDR report key: 8687819 · Received June 11, 2019

    Report

    Report Number
    3006967710-2019-00003
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Report Date
    May 13, 2019
    Manufacturer
    CME AMERICA, LLC
    Product Code
    FRN
    PMA / PMN Number
    K042696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER REPORTED THERE WAS AN OVER INFUSION OF GREATER THAN 50% BECAUSE THE REMAINING FLUID REPORTED BY THE PUMP WAS DIFFERENT THAN THE AMOUNT REMAINING IN THE SYRINGE. THE EVENT LOG SHOWS THE INFUSION BEGAN ON (B)(6) 2019, AND THE REPORTED INCIDENT WAS THE NEXT DAY. THE CUSTOMER ALSO STATED THAT THEY PERFORMED THEIR OWN VOLUME TEST AFTER THE REPORTED OVER-INFUSION BUT COULD NOT DUPLICATE THE OVER-DELIVERY. WE PERFORMED OUR OWN VOLUME TESTING USING BOTH THE USER'S PARAMETERS AND THE SERVICE MANUAL PARAMETERS, WE FOUND THE DEVICE DELIVERS WITHIN SPECIFICATION FOR EACH TEST DELIVERY. THE INFUSION IN QUESTION WAS A BOLUS ONLY PROTOCOL WITH NO BASAL RATE. WE MIMICKED THE INFUSION USING THE SAME ADMINISTRATION SET AND SYRINGE. THE SYRINGE WAS FILLED WITH 27ML OF FLUID AND THE INFUSION INITIATED. FOLLOWING THE EVENT LOG AND USING THE CUSTOMER'S PARAMETERS, WE RAN THEIR INFUSION AND INITIATED BOLUS DELIVERIES AT THE SAME TIME AS THE EVENT LOG DOCUMENTS. AT THE END OF THE INFUSION, THE SYRINGE HAD EXACTLY 11ML LEFT, AS WAS EXPECTED. WE FOUND NO ISSUES WITH THE PUMP OR THE PROTOCOL AS DOCUMENTED IN THE EVENT LOG. WE WERE UNABLE TO DUPLICATE THE COMPLAINT ISSUE, THE DEVICE PASSED TESTING AND OPERATED AS EXPECTED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT THE DEVICE OVER DELIVERED DURING PATIENT USE, A SYRINGE WAS USED WITH THE PCA PUMP. THERE WAS NO PATIENT HARM.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION INTO THE REPORTED EVENT IS ON-GOING AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE OVER DELIVERED, THERE WAS NO PATIENT HARM. (B)(4) IS CONDUCTING AN INVESTIGATION INTO THE OCCURRENCE AND THE CAUSE OF THE OVER DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483057 BODYGUARD 575 COLORVISION INFUSION PUMP BG 575 CV PUMP FRN CME AMERICA, LLC 100-620XCV

    Patients

    Seq Age Sex Outcome Treatment
    1