BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLUMAT MC AGILIA GB

    MDR report key: 15801945 · Received November 15, 2022

    Report

    Report Number
    3000240707-2022-00227
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    October 19, 2022
    Report Date
    April 12, 2023
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTS THE FOLLOWING: "COMPLAINT REPORT RECEIVED FROM (B)(6) HOSPITAL TO REPORT PUMP OVER INFUSING. PUMP SERIAL NUMBER (B)(4) OVER INFUSED. 250MCG OF DIGOXIN ADMINISTERED AS PXB. VOLUMAT PUMP SET TO 50MLS OVER 1H20MINS. AFTER 10MINS ALL THE DIGOXIN HAD GONE THROUGH, DESPITE THE VOLUMAT PUMP STATING THAT IT HAD 57MINS LEFT WITH 35.3MLS LEFT TO RUN THROUGH. DEVICE TAKEN OUT OF USE. TO BE [SENT] TO FIELD SERVICE ENGINEER." REPORTING DUE TO THE REFERENCED ISSUE; NO HARM TO PATIENT WAS REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 0

    DEVICE HISTORY RECORD WAS REVIEWED. NO EVENT LINKED WITH THE REPORTED ISSUE WAS OBSERVED. PROVIDED HISTORY LOG IS FROM 22NOV2022 TO 11JAN2023 BUT REPORTED EVENT WAS ON 19OCT2022. DUE TO A LIMIT OF DOWNLOADABLE DATA WHICH IS 869 ELEMENTS THE REPORTED EVENT DATAS COULD NOT BE INCLUDED IN THE EXTRACTED HISTORY LOG. THEREFORE NO ANALYSIS COULD BE PERFORMED ON THE EVENT REPORTED DATE. THE REPORTED DEVICE WAS NOT RETURNED TO BRÉZINS FOR INVESTIGATION BUT WAS CHECKED LOCALLY. DUE TO THE UNABILITY TO GET THE HISTORY LOG DATAS FROM THE REPORTED EVENT DATE, THE CONDITION OF USE OF THE DEVICE REMAIN UNCLEAR. HOWEVER QUALITY CONTROL WAS PERFORMED AND NO TECHNICAL OR FUNCTIONAL ISSUE WAS OBSERVED AND THE INFORMATION THAT NO REPAIR WAS PERFORMED ON THE DEVICE WAS ALSO PROVIDED. THIS COMPLAINT IS CONSIDERED AS NOT VALID. FOR THIS ISSUE AS PER OUR LOCAL PROCEDURE, WE INITIATED NO ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181710 VOLUMAT MC AGILIA GB INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown