BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVOSET INFUSION PUMP ROW

    MDR report key: 23875487 · Received December 23, 2025

    Report

    Report Number
    3010293992-2025-00087
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Report Date
    April 15, 2026
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    7290109152097
    PMA / PMN Number
    K213744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EITAN MEDICAL REQUESTED THE PUMP AND THE EVENT LOG FOR INVESTIGATION. TO DATE, NONE HAVE BEEN 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP. INVESTIGATION FINDINGS: NO INDICATION OF ANY FAILURE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT WAS OBSERVED. THE PUMP'S ACCURACY WAS TESTED AND FOUND TO MEET SPECIFICATIONS. CONCLUSION: THE PUMP'S ACCURACY MEETS SPECIFICATIONS. NO FAILURE WAS FOUND. 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.

    Additional Manufacturer Narrative · 0

    EITAN MEDICAL HAS CONDUCTED ATTEMPTS TO RECEIVE THE EVENT LOG OF PUMP, AS WELL AS THE PUMP ITSELF, FOR INVESTIGATION. HOWEVER, NEITHER WAS PROVIDED BY THE CUSTOMER. AS A RESULT, A COMPREHENSIVE INVESTIGATION OF THIS EVENT COULD NOT BE CONDUCTED. IF THE EVENT LOG AND/OR THE PUMP ARE PROVIDED BY THE CUSTOMER, AN INVESTIGATION WILL BE CONDUCTED, AND THE INVESTIGATION'S FINDINGS WILL BE PRESENTED 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 FRANCE. A DELIVERY ISSUE WAS REPORTED. NO HUMAN HARM AND 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.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. A DELIVERY ISSUE WAS REPORTED. IT WAS REPORTED NO HUMAN HARM OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 0

    THIS EVENT WAS ORIGINALLY REPORTED WITH THE FOLLOWING INFO: THE CUSTOMER REPORTED AN ALLEGED OVER DELIVERY OF UNKNOWN DRUG. ACCORDING TO THE CUSTOMER, THE PUMP ENDED THE INFUSION BEFORE THE SCHEDULED TIME. NO HUMAN HARM AND NO MEDICAL INTERVENTION WAS 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. SINCE THEN, THE FOLLOWING NEW INFORMATION WERE RECEIVE FROM THE CUSTOMER: THE CUSTOMER REPORTED AN ALLEGED OVER DELIVERY OF 5FU. ACCORDING TO THE CUSTOMER, THE PUMP ENDED THE INFUSION BEFORE THE SCHEDULED TIME. IT WAS REPORTED NO HUMAN HARM WAS OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2769158 AVOSET INFUSION PUMP ROW AVOSET INFUSION PUMP ROW FRN EITAN MEDICAL LTD. 7290109152097

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown