BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE M.T INFUSION PUMP - GERMAN

    MDR report key: 22931933 · Received September 2, 2025

    Report

    Report Number
    3010293992-2025-00059
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    July 30, 2025
    Report Date
    November 20, 2025
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    7290109150802
    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: A SMALL DEVIATION WAS OBSERVED IN ONE OF THE TREATMENTS FOUND IN THE EVENT LOG. THE INVESTIGATION ESTABLISHED THIS IS RELATED TO THE PUMP'S SMALL POSITIVE ACCURACY COMPENSATION UNDER BACKPRESSURE CONDITIONS. THE PUMP'S ACCURACY WAS TESTED UNDER NORMAL CONDITIONS AND FOUND TO MEET SPECIFICATIONS. FURTHERMORE, THE PUMP WAS VISUALLY INSPECTED AND NO DAMAGE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT WAS IDENTIFIED. CONCLUSION: A SMALL DEVIATION WAS OBSERVED IN ONE OF THE TREATMENTS FOUND IN THE EVENT LOG. THE INVESTIGATION ESTABLISHED THIS IS RELATED TO THE PUMP'S SMALL POSITIVE ACCURACY COMPENSATION UNDER BACKPRESSURE CONDITIONS. NO ADDITIONAL FACTORS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT WERE FOUND. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP AND ITS EVENT LOG. INVESTIGATION FINDINGS: THE PUMP'S ACCURACY WAS TESTED AND FOUND TO MEET SPECIFICATIONS. HOWEVER, A SMALL DEVIATION WAS OBSERVED IN THE EVENT LOG. CONCLUSION: NO INVESTIGATION CONCLUSION IS AVAILABLE YET. EITAN MEDICAL CONTINUES TO INVESTIGATE THIS COMPLAINT. 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.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516006 SAPPHIRE M.T INFUSION PUMP - GERMAN INFUSION PUMP FRN EITAN MEDICAL LTD. 7290109150802

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown