BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAPPHIRE M.T INFUSION PUMP - GERMAN

    MDR report key: 21916774 · Received April 28, 2025

    Report

    Report Number
    3010293992-2025-00031
    Event Type
    Death
    Date Received
    April 28, 2025
    Date of Event
    April 19, 2025
    Report Date
    June 9, 2025
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    7290109150802
    PMA / PMN Number
    K192860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    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: K161667.

    Additional Manufacturer Narrative · 0

    INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP'S EVENT LOG. INVESTIGATION FINDINGS: THE EVENT WAS CONFIRMED TO BE SOLELY A RESULT OF A PROGRAMMING ERROR. THE PUMP FUNCTIONED AS DESIGNED AND DELIVERED THE INFUSION IN ACCORDANCE WITH THE PROGRAMED PARAMETERS. CONCLUSION: THE EVENT WAS CONFIRMED TO BE A RESULT OF A PROGRAMMING ERROR. THE SAPPHIRE PUMP DESIGN MINIMIZES PROGRAMMING ERRORS BY REQUIRING USERS TO REVIEW AND APPROVE PARAMETERS BEFORE STARTING OR REPEATING INFUSIONS, WITH CLEAR ON-SCREEN DISPLAYS THROUGHOUT. 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

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

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM GERMANY. A PROGRAMMING ERROR WHICH RESULTED IN PATIENT DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413271 SAPPHIRE M.T INFUSION PUMP - GERMAN INFUSION PUMP FRN EITAN MEDICAL LTD. 7290109150802

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death