BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLUMAT MC AGILIA

    MDR report key: 9249882 · Received October 29, 2019

    Report

    Report Number
    3000240707-2019-00069
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    September 28, 2019
    Report Date
    October 1, 2019
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    THE DEVICE WAS NOT RECEIVED FOR INVESTIGATION BUT DEVICE HISTORY LOG WAS PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED, NO EVENT LINKED TO THE REPORTED ISSUE WAS OBSERVED. DEVICE LOG WAS REVIEWED. FOR (B)(6): INFUSION HAS BEEN DONE @ 80 ML/H FROM 00:19 (PREVIOUS DAY ON (B)(6) INFUSION HAD BEEN DONE @ 84 ML/H). INFUSION TIME IS 12.61 HRS, FROM 00:19 TO 13:19, WITH 37 MINUTES IN STOP MODE. TOTAL VOLUME INFUSED FROM 00:19 TO 13:19 = 1021 ML (INCLUDING 6 SIMPLE BOLUS FOR AROUND 30 ML). NOTHING MATCH WITH DESCRIPTION AND COMPLEMENTARY INFORMATION RECEIVED. FOR (B)(6): INFUSION HAS BEEN DONE @ 250 ML/H FROM 13:07 TO 15:04. INFUSION TIME IS 1:57 HRS, UNTIL STOP MODE. INFUSION IS RE-STARTED @ 120 ML/H FOR 10 MINUTES. THIS INFUSION SEEMS TO MATCH WITH REPORTED EVENTS, BUT INFUSION TIME HAS BEEN WELL 2 HOURS AND NOT 1.5 HOUR. UPON DEVICE LOG REVIEW, FOR (B)(6): INFORMATION DID NOT MATCH THE DESCRIBED EVENT AND FOR (B)(6) THE INFUSION LASTED 2 HOURS AND NOT 1.5 HOUR WHICH CANNOT CONFIRMED THE REPORTED EVENT EITHER. COMPARISON BETWEEN VOLUME RECORDED IN LOG AND CALCULATED VOLUME FOUND THAT CALCULATED VOLUMES CORRESPONDS AT RECORDED VOLUMES. FROM THE INFORMATION THAT ARE AVAILABLE TO US THE REPORTED EVENT CANNOT BE CONFIRMED AND THEREFORE ITS CAUSE REMAINS UNKNOWN. THIS COMPLAINT IS NOT CONFIRMED. NO ACTION WAS INITIATED FOR THIS EVENT AS PER OUR LOCAL PROCEDURES HOWEVER THE COMPLAINT HAS BEEN REGISTERED FOR STATISTICAL MONITORING. THE TREND IS NORMAL AND REPORTED RISK IS LOWER THAN ESTIMATED RISK.

    Description of Event or Problem · 1

    POTENTIAL OVERDOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045921 VOLUMAT MC AGILIA INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1