BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA SP MC WIFI GB

    MDR report key: 16500413 · Received March 7, 2023

    Report

    Report Number
    3004548776-2023-00053
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    December 22, 2022
    Report Date
    May 17, 2023
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DEVICE HISTORY RECORD WAS REVIEWED, NO ISSUE HAS BEEN FOUND. DEVICE HISTORY LOG WAS REVIEWED, AND EVENT IS CONFIRMED. SOME ERROR 01 ARE PRESENT IN THE LOG FILE. THE SUBJECT DEVICE (MODEL AGILIA SP MC WIFI GB, SERIAL NUMBER (B(6)) WAS SENT BACK TO OUR LABORATORY FOR ANALYSIS. UPON RECEPTION, THE SUBJECT PART WAS SUBMITTED TO SEVERAL TESTS WITH DIFFERENT FLOWRATE AND PRESSURE TO CONFIRM THE REPORTED DEFECT. THE REPORTED ERROR HAS NOT BEEN TRIGGERED BY THESE TESTS. HOWEVER, DURING THE INTERNAL CHECK IT WAS NOTICED THAT THE MOTOR AXIS IS TOO LONG AND RUBS AGAINST THE UPPER CASE. THIS FRICTION CAUSES PLASTIC PARTICLES WHICH LODGE IN THE GEARS, AND BY CONSEQUENCE CAN TRIGGER THE TECHNICAL ERROR 01 AT ONE MOMENT (DEPENDING ON THIS LOCATION ON THE GEAR). THE ROOT CAUSE OF THE REPORTED EVENT IS DUE TO THE DEVICE DESIGN (MOTOR AXIS TOO LONG). AN ACTION WAS INITIATED TO AVOID THIS TYPE OF ISSUE IN THE FUTURE. THE DEVICE WAS PRODUCED BEFORE THE IMPLEMENTATION OF THE ACTION. THIS COMPLAINT HAS BEEN REGISTERED FOR STATISTICAL MONITORING. THIS COMPLAINT IS CONSIDERED AS VALID. THE TREND IS NORMAL. THE REPORTED RISK IS LOWER COMPARED TO THE ESTIMATED RISK. FOR THIS ISSUE AS PER OUR LOCAL PROCEDURE, WE INITIATED AN ACTION.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: "PATIENT COMMENCED ON SLIDING SCALE FROM ED. RUNNING TO SCHEDULE UNTIL APPROX 10AM WHEN PUMP STARTED ALARMING OCCLUSION DESPITE FLUSHING/MAKING SURE LINE UNCLAMPED. VOLUME OF FLUID IN SYRINGE DID NOT DROP BELOW 5MLS FOR 3 HRS APPROX. NOT CONCERNED INITIALLY AS PATIENT DISCONNECTED FOR A PERIOD OF TIME TO USE TOILET, DON GOWN FOR THEATRE ETC. HOWEVER, AT APPROX 11:15 PUMP ALARMING ERROR 001 - ROTATION PROBLEM. IT BECAME EVIDENT THAT PUMP FAULTY AND NOT DRIVING SYRINGE TO ADMINISTER MEDICATION. PATIENT HAD NOT RECEIVED APPROX 6-8 UNITS OF INSULIN FOR THREE HOURS DUE TO THIS. PT'S BLOOD SUGARS REMAINED AT HIGHER END OF NORMAL THROUGHOUT THIS. " REPORTING DUE TO THE REFERENCED ISSUE (ERROR 01); NO SERIOUS INJURIES WERE REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736203 AGILIA SP MC WIFI GB INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown