BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVOSET INFUSION PUMP ROW

    MDR report key: 25030972 · Received April 29, 2026

    Report

    Report Number
    3010293992-2026-00035
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Report Date
    April 29, 2026
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    7290109152097
    PMA / PMN Number
    K213744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EITAN MEDICAL REQUESTED ADDITIONAL INFORMATION ABOUT THE EVENT FROM THE CUSTOMER AND THE PUMP AND EVENT LOG FOR INVESTIGATION. TO DATE, NONE WERE RECEIVED. WHEN RECEIVED, THE INVESTIGATION FINDINGS WILL BE DETAILED IN A FOLLOW-UP REPORT. THIS REPORTED EVENT OCCURRED OUTSIDE OF THE US ON A DEVICE THAT IS SIMILAR TO THE ONE MARKETED IN THE US AND FOR WHICH THERE IS NO DATA IN GUDID. DEVICE'S PREMARKET SUBMISSION NUMBER: K213744.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM UK. A DELIVERY ISSUE WAS REPORTED. IT WAS REPORTED NO HUMAN HARM OCCURRED. NO MEDICAL INTERVENTION WAS REPORTED. THE TYPE OF DRUG DURING THE EVENT WAS NOT REPORTED. SINCE THE LIKELIHOOD OF CAUSING OR CONTRIBUTING TO DEATH OR SERIOUS INJURY COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION ABOUT THE TYPE OF DRUG INVOLVED, THE COMPLAINT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144678 AVOSET INFUSION PUMP ROW INFUSION PUMP FRN EITAN MEDICAL LTD. 7290109152097

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown