BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SAPPHIRE PUMP

    MDR report key: 24232621 · Received February 2, 2026

    Report

    Report Number
    3010293992-2026-00006
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Report Date
    February 2, 2026
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS UNWILLING TO PROVIDE THE SERIAL NUMBER OF THE PUMP INVOLVED IN THE EVENT AND CONFIRMED THAT NO PUMP WOULD BE RETURNED FOR INVESTIGATION AND NO ADDITIONAL INFORMATION WOULD BE PROVIDED. AS A RESULT, THE INVESTIGATION COULD NOT BE PERFORMED DUE TO INSUFFICIENT INFORMATION, INCLUDING THE ABSENCE OF THE PUMP SERIAL NUMBER AND EVENT LOG. NO FURTHER DETAILS REGARDING THE EVENT WERE AVAILABLE. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM ISRAEL. A DELIVERY ISSUE WAS REPORTED. IT WAS REPORTED THAT NO HUMAN HARM OCCURRED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291138 UNKNOWN SAPPHIRE PUMP INFUSION PUMP FRN EITAN MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown