BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE INFUSION PUMP- ENGLISH

    MDR report key: 23049398 · Received September 15, 2025

    Report

    Report Number
    3010293992-2025-00062
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    April 30, 2025
    Report Date
    November 27, 2025
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    7290109150284
    PMA / PMN Number
    K192860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EITAN MEDICAL REQUESTED THE PUMP, EVENT LOG AND BOLUS HANDLE FOR INVESTIGATION. TO DATE, NONE HAVE BEEN RECEIVED. WHEN RECEIVED, 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP AND ITS EVENT LOG. INVESTIGATION FINDINGS: NO INDICATION OF UNREQUESTED BOLUSES WAS OBSERVED. CONCLUSION: THE PUMP INFUSED WITHOUT ANY IRREGULARITIES AND WAS FOUND TO MEET ITS SPECIFICATIONS, INCLUDING ACCURACY. 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: K1928603.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM AUSTRALIA. A DELIVERY ISSUE WAS REPORTED. IT WAS REPORTED THAT THIS EVENT DID NOT OCCUR DURING PATIENT USE.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM AUSTRALIA. A DELIVERY ISSUE WAS REPORTED. IT WAS REPORTED THAT THIS EVENT DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061668 SAPPHIRE INFUSION PUMP- ENGLISH INFUSION PUMP FRN EITAN MEDICAL LTD. 7290109150284

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown