BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE M.T INFUSION PUMP - FRENCH

    MDR report key: 21675455 · Received March 24, 2025

    Report

    Report Number
    3010293992-2025-00021
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    February 24, 2025
    Report Date
    June 26, 2025
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    7290109150710
    PMA / PMN Number
    K161667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP INVOLVED IN THIS EVENT. INVESTIGATION FINDINGS: THE PUMP INFUSED WITHOUT ANY IRREGULARITIES AND WAS FOUND TO MEET ITS SPECIFICATIONS. CONCLUSION: THE PUMP INFUSED WITHOUT ANY IRREGULARITIES, AND NO INDICATION OF OVER DELIVERY WAS OBSERVED. 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: K161667.

    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: K192860.

    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: K192860.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. A DELIVERY ISSUE WAS REPORTED. NO HUMAN HARM OR 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.

    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
    707782 SAPPHIRE M.T INFUSION PUMP - FRENCH INFUSION PUMP FRN EITAN MEDICAL LTD. 7290109150710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown