BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE INFUSION PUMP- ENGLISH

    MDR report key: 24066221 · Received January 14, 2026

    Report

    Report Number
    3010293992-2026-00005
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    December 29, 2025
    Report Date
    March 26, 2026
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    7290109153339
    PMA / PMN Number
    K192860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP. INVESTIGATION FINDINGS: NO INDICATION OF ANY FAILURE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT WAS OBSERVED. THE PUMP'S ACCURACY WAS TESTED AND FOUND TO MEET SPECIFICATIONS. CONCLUSION: THE PUMP'S ACCURACY MEETS SPECIFICATIONS. NO FAILURE WAS 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

    EITAN MEDICAL REQUESTED ADDITIONAL INFORMATION ABOUT THE EVENT FROM THE CUSTOMER, THE PUMP AND EVENT LOG FOR INVESTIGATION. TO DATE, NONE WERE 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.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM UK. A DELIVERY ISSUE WAS REPORTED. IT WAS REPORTED THAT NO HUMAN HARM OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. SINCE THE LIKELIHOOD OF CAUSING OR CONTRIBUTING TO DEATH OR SERIOUS INJURY COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION ABOUT THE TYPE OF DRUG INVOLVED, THE COMPLAINT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM UK. A DELIVERY ISSUE WAS REPORTED. IT WAS REPORTED THAT NO HUMAN HARM OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. SINCE THE LIKELIHOOD OF CAUSING OR CONTRIBUTING TO DEATH OR SERIOUS INJURY COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION ABOUT THE TYPE OF DRUG INVOLVED, THE COMPLAINT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134763 SAPPHIRE INFUSION PUMP- ENGLISH INFUSION PUMP FRN EITAN MEDICAL LTD. 7290109153339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown