BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVOSET INFUSION PUMP ROW

    MDR report key: 21688186 · Received March 25, 2025

    Report

    Report Number
    3010293992-2025-00024
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    March 12, 2025
    Report Date
    June 30, 2025
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EITAN MEDICAL HAS CONDUCTED MULTIPLE 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP AND ITS EVENT LOG. INVESTIGATION FINDINGS: THE PUMP WAS TESTED, INCLUDING ACCURACY, AND WAS FOUND TO MEET SPECIFICATIONS. CONCLUSION: AS THE PUMP WAS FOUND TO MEET SPECIFICATIONS. (I) THE EXPERIENCED OCCLUSION ALARMS ARE MOST LIKELY DUE TO AN EMPTY BAG AT THE END OF THE TREATMENT AND (II) THE ALLEGED OVER DELIVERY (TREATMENT ENDING PRIOR TO THE EXPECTED TIME) IS MOST LIKELY RELATED TO SET-UP OR EXTERNAL FACTORS. 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

    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. THE CUSTOMER STATED THAT NO HUMAN HARM OCCURRED. NO MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. A DELIVERY ISSUE WAS REPORTED. IT WAS REPORTED THAT NO HUMAN HARM OCCURRED AS A RESULT OF THIS EVENT. NO MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320053 AVOSET INFUSION PUMP ROW INFUSION PUMP FRN EITAN MEDICAL LTD. 7290109152097

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown