BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVOSET INFUSION PUMP ROW

    MDR report key: 22304464 · Received June 22, 2025

    Report

    Report Number
    3010293992-2025-00044
    Event Type
    Malfunction
    Date Received
    June 22, 2025
    Date of Event
    June 8, 2025
    Report Date
    September 30, 2025
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FRN
    PMA / PMN Number
    K213744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP'S EVENT LOG. INVESTIGATION FINDINGS: THE DEVICE APPEARS TO HAVE FUNCTIONED ACCORDING TO THE PARAMETERS. HOWEVER, THE ACCURACY OF DELIVERY CANNOT BE CONFIRMED WITHOUT TESTING THE PUMP. CONCLUSION: EITAN MEDICAL REQUESTED THE PUMP TO BE RECEIVED FOR INVESTIGATION. WHEN RECEIVED, THE PUMP WILL BE TESTED, AND THE TEST RESULTS 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP INVOLVED IN THE EVENT. INVESTIGATION FINDINGS: THE COMPLAINT WAS NOT CONFIRMED. THE PUMP INFUSED WITHOUT ANY IRREGULARITIES AND WAS FOUND TO MEET ITS SPECIFICATIONS. CONCLUSION: THE PUMP INFUSED WITHOUT ANY IRREGULARITIES. THE PUMP WAS FOUND TO MEET ITS SPECIFICATIONS AND SUCCESSFULLY PASSED ACCURACY TESTING. 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 UNITED KINGDOM. A DELIVERY ISSUE WAS REPORTED. IT WAS REPORTED THAT NO HUMAN HARM OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM UNITED KINGDOM. A DELIVERY ISSUE WAS REPORTED. IT WAS REPORTED THAT NO HUMAN HARM OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430497 AVOSET INFUSION PUMP ROW INFUSION PUMP FRN EITAN MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown