BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA VP MC WIFI CO

    MDR report key: 19805457 · Received July 23, 2024

    Report

    Report Number
    3000240707-2024-00244
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 14, 2024
    Report Date
    October 1, 2024
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: "REPORT OF EVENT OCCURRED ON 06/14/2024. THE PATIENT WAS BEING TREATED FOR HIS DIAGNOSIS OF ARTERIAL HYPERTENSION, PERMANENT AURICULAR FIBRILATION. HOWEVER, THERE IS NO INDICATION THAT HE DEVELOPED THESE CONDITIONS DUE TO THE USE OF THE INFUSION PUMP. THE PATIENT WAS STARTED ON NITROGLYCERIN 0.2MG/ML X 250 ML IN 5% DEXTROSE WHICH IS ADMINISTERED IN INFUSION PUMP SERIES # (B)(6) PASSING IN BOLUS BETWEEN 23:00 AND 01:00 AM. AT 00:00 AM VARIABILITY IN THE PATIENT'S VITAL SIGNS WAS EVIDENCED AS FOLLOWS: BLOOD PRESSURE: 106/76. MEAN BLOOD PRESSURE 84. HEART RATE: 53. THE CLIENT ASKED US TO CHECK THE DATA FROM THE INFUSION PUMP, AS HE SUSPECTED THAT THE MEDICATION HAD PASSED MORE QUICKLY THAN EXPECTED, AND TO CONFIRM IF THAT IT HAD FOLLOWED THE PROGRAMMING IN THE DEVICE. THE CUSTOMER INDICATED THAT THE PATIENT HAD NO COMPLICATIONS, AND HIS CURRENT CONDITION WAS "HE IS NOW IN GOOD GENERAL CONDITION AND HAS BEEN DISCHARGED TO HOME CARE". BEFORE PROGRAMMING THE PUMP INFUSION, THE PATIENT'S BLOOD PRESSURE WAS: BLOOD PRESSURE: 160/111 MEAN ARTERIAL PRESSURE: 125. WE ALSO HAD OTHER RECORDS OF THE SIGNS ON THE DAY OF THE SITUATION: TIME 23:00 BP: 160/111 MBP 125 SPO2 99%. TIME 00:00 BP: 106/76 MBP 84 SPO2 91%. TIME 01:00 BP 114/62 MBP 76 SPO2 90%. TIME 02:00 BP 98/83 MBP 90 SPO2 89% HOUR 02:00 BP 98/83 MBP 90 SPO2 89. REPORTING AS A CONSERVATIVE MEASURE FOR A SUSPECTED OVERFLOW. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 0

    DEVICE HISTORY RECORD WERE REVIEWED AND NOTHING WAS FOUND RELATED TO THE REPORTED EVENT. DEVICE LOG WAS REVIEWED AND NOTHING WAS FOUND THAT COULD CONFIRM THE REPORTED EVENT. ALL DATAS FOUND SHOWED THAT CALCULATED VOLUME MATCHES RECORDED VOLUME. EACH IDENTIFIED INFUSED VOLUMES WERE IN LINE WITH THE DEVICE PROGRAMMING. THE REPORTED DEVICES WERE NOT RETURNED TO BRÉZINS FOR INVESTIGATION AS DEVICES CHECK WERE CARRIED OUT LOCALLY. NO ISSUE COULD BE FOUND UPON TESTING. DEVICE QUALITY CONTROL CERTIFICATES WERE PROVIDED. DEVICE HISTORY LOGS WERE REVIEWED BY OUR INVESTIGATOR IN BRÉZINS. EACH IDENTIFIED INFUSED VOLUMES WERE IN LINE WITH THE DEVICE PROGRAMMING. THE INFUSION OF NITROGLYCERIN STARTED AT 93.75ML/H AND WAS INTERRUPTED BY AN AIR ALARM. AS PER PROVIDED QUALITY CONTROL CERTIFICATES, NO DYSFUNCTION OF THE DEVICE COULD BE FOUND. APART FROM PROVIDED QUALITY CONTROL CERTIFICATE EDITED UPON LOCAL CHECK OF THE DEVICES; NO OTHER INFORMATION WERE PROVIDED REGARDING ANY EVENTUAL REPAIRS MADE ON THE DEVICES. 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
    935893 AGILIA VP MC WIFI CO INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown