BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA VP MC WIFI AU

    MDR report key: 14664289 · Received June 11, 2022

    Report

    Report Number
    3004548776-2022-00064
    Event Type
    Malfunction
    Date Received
    June 11, 2022
    Date of Event
    May 13, 2022
    Report Date
    October 28, 2022
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NEW BAG OF HEPARIN HUNG AND STARTED USING "SAME INFUSION" FUNCTION RUNNING AT A RATE OF 12 ML/HR (1200 UNITS/HR). INFUSIONS STARTED, NO LOADING DOSE OR BOLUS ADMINISTERED ACCORDING TO INSIGHT REPORT. PUMP ALARMED APPROXIMATELY 15 MINUTES AFTER STARTING THE NEW BAG WITH AN "UPSTREAM OCCLUSION ALARM". NURSE LOOKING AFTER THE PATIENT NOTICED THAT 200 ML OF THE 250 ML BAG HAD BEEN ADMINISTERED TO THE PATIENT SINCE THE BAG WAS CHANGED DESPITE PUMP BEING CORRECTLY PROGRAMMED AT 12 ML/HR. APTT COLLECTED WITH SIGNIFICANT INCREASE AND INFUSION WITHHELD TO ALLOW APTT TO RETURN TO THERAPEUTIC RANGE. INFUSION STARTED AT 9.20 AM. REPORTING FOR OVERDOSE AS A CONSERVATIVE MEASURE. NO OTHER PATIENT ISSUES WERE REPORTED. MORE FOLLOW UP INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 0

    DEVICE HISTORY RECORD WAS REVIEWED BUT NOTHING LINKED TO THE REPORTED EVENT WAS OBSERVED. DEVICE HISTORY LOG WAS REVIEWED. THE LOGS ARE AT DATE OF 2 AND 3 APRIL. IN FIRST, DRUG SELECTION HEPARIN DONE AT 12:03 PM START INFUSION AT 12:08 PM NO OTHER EVENTS THAN MAINS DISCONNECTION AND (RE) CONNECTION UNTIL USER STOP AT 2:24 AM ON 3 APRIL; RESTART DONE 3 MINUTES LATER. VI = 170 ML. AT 9:01 AM, AN UPSTREAM OCCLUSION IS TRIGGERED, JUST BEFORE THE VTBI OF 250 ML REACHED (PROBABLY UPSTREAM DETECTION OF END OF BAG). VTBI ALARM DONE AFTER RESTART 3 MINUTES AFTER. RESTART AT 9:21 AM AND 3 MINUTES LATER, UPSTREAM OCCLUSION IS TRIGGERED: RESTART AT 9:28 AM AND 3 MINUTES LATER, A NEW UPSTREAM OCCLUSION IS TRIGGERED: TOTAL VOLUME INFUSED = 251 ML UPON THE DATA LOG ANALYSIS, THE INVESTIGATOR MADE A COMPARISON BETWEEN VOLUMES RECORDED IN LOG AND CALCULATED VOLUMES. AND HE FOUND THAT CALCULATED VOLUMES CORRESPOND AT RECORDED VOLUMES. THE TIMING TO TRIGGER THE 2 UPSTREAM ALARMS AFTER RESTART IS EACH TIME 3 MINUTES ON LOG. IT COULD CONFIRM AN ISSUE ON THE LINE/TUBING SET (CLAMP CLOSED, LEAKAGE). THE REPORTED DEVICE WAS NOT SENT BACK TO BRÉZINS, SO NO INVESTIGATION COULD BE PERFORMED. THEREFORE, THE REPORTED ISSUE COULD NOT BE CONFIRMED FOLLOWING THE DATA LOG ANALYSIS AND THE ROOT CAUSE REMAINS UNKNOWN. 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
    52402 AGILIA VP MC WIFI AU INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other