BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE M.T INFUSION PUMP - FRENCH

    MDR report key: 22094184 · Received May 28, 2025

    Report

    Report Number
    3010293992-2025-00037
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    April 29, 2025
    Report Date
    October 23, 2025
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    7290109150710
    PMA / PMN Number
    K192860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EITAN MEDICAL HAS CONDUCTED MULTIPLE ATTEMPTS TO RECEIVE THE EVENT LOG OF PUMP, AS WELL AS THE PUMP ITSELF, FOR INVESTIGATION. HOWEVER, NEITHER WAS PROVIDED BY THE CUSTOMER. AS A RESULT, A COMPREHENSIVE INVESTIGATION OF THIS EVENT COULD NOT BE CONDUCTED. IF THE EVENT LOG AND/OR THE PUMP ARE PROVIDED BY THE CUSTOMER, AN INVESTIGATION WILL BE CONDUCTED, AND THE INVESTIGATION'S FINDINGS WILL BE PRESENTED 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

    EITAN MEDICAL REQUESTED THE PUMP AND THE EVENT LOG 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 INVOLVED IN THE EVENT. INVESTIGATION FINDINGS: THE INVESTIGATION FOUND MULTIPLE SIGNS OF MISUSE. CONCLUSION: THE REPORTED DELIVERY ISSUE WAS CAUSED BY USER-INDUCED PHYSICAL DAMAGE (MISUSE.) NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. 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 FRANCE. A DELIVERY ISSUE WAS REPORTED. THE CUSTOMER STATED THAT NO HUMAN HARM OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. A DELIVERY ISSUE WAS REPORTED. THE CUSTOMER STATED THAT NO HUMAN HARM OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM (B)(6). A DELIVERY ISSUE WAS REPORTED. THE CUSTOMER STATED THAT NO HUMAN HARM OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332172 SAPPHIRE M.T INFUSION PUMP - FRENCH INFUSION PUMP FRN EITAN MEDICAL LTD. 7290109150710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown