BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE M.T INFUSION PUMP - GERMAN

    MDR report key: 22931912 · Received September 2, 2025

    Report

    Report Number
    3010293992-2025-00058
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 5, 2025
    Report Date
    October 8, 2025
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FRN
    PMA / PMN Number
    K192860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP AND ITS EVENT LOG. INVESTIGATION FINDINGS: NO OVER DELIVERY WAS OBSERVED IN THE EVENT LOG (DURING THE CUSTOMER'S TREATMENTS) NOR DURING THE REPRODUCTION ATTEMPT PERFORMED BY EITAN MEDICAL. THE PUMP'S ACCURACY WAS TESTED AND FOUND TO MEET SPECIFICATIONS. CONCLUSION: THE COMPLAINT WAS NOT CONFIRMED. NO OVER DELIVERY WAS OBSERVED. THE PUMP'S ACCURACY WAS TESTED AND FOUND TO MEET SPECIFICATIONS. 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

    EVENT LOG HAS BEEN RECEIVED AND IS CURRENTLY UNDER INVESTIGATION. INVESTIGATION FINDINGS WILL BE PROVIDED IN THE 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 GERMANY. A DELIVERY ISSUE WAS REPORTED. NO HUMAN HARM AND NO MEDICAL INTERVENTION OCCURRED AS A RESULT OF THIS COMPLAINT.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM GERMANY. A DELIVERY ISSUE WAS REPORTED. NO HUMAN HARM AND NO MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2865156 SAPPHIRE M.T INFUSION PUMP - GERMAN INFUSION PUMP FRN EITAN MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown