BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE INFUSION PUMP

    MDR report key: 23741521 · Received December 8, 2025

    Report

    Report Number
    3010293992-2025-00082
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Report Date
    February 23, 2026
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FRN
    PMA / PMN Number
    K192860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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: K192860.

    Additional Manufacturer Narrative · 0

    EITAN MEDICAL REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER, THE PUMP'S SERIAL NUMBER, THE PUMP ITSELF, AND THE EVENT LOG. TO DATE, NONE OF THESE HAVE BEEN RECEIVED. ONCE THE INFORMATION IS PROVIDED, 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: K192860.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM BELGIUM. A DELIVERY ISSUE WAS REPORTED. NO HUMAN HARM AND NO MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. SINCE THE LIKELIHOOD TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY COULD NOT BE DETERMINED DUE TO LACK OF INFORMATION REGARDING THE TYPE OF DRUG THE COMPLAINT WILL BE REPORTED FROM ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM BELGIUM. A DELIVERY ISSUE WAS REPORTED. NO HUMAN HARM AND NO MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. SINCE THE LIKELIHOOD TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY COULD NOT BE DETERMINED DUE TO LACK OF INFORMATION REGARDING THE TYPE OF DRUG THE COMPLAINT WILL BE REPORTED FROM ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140406 SAPPHIRE INFUSION PUMP INFUSION PUMP FRN EITAN MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown