BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUSHING PUMP OFP-2 (EU)

    MDR report key: 24676664 · Received March 24, 2026

    Report

    Report Number
    9611174-2026-00065
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Report Date
    April 16, 2026
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    FEQ
    PMA / PMN Number
    K100899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, D9, H2, H3, H4, H6, H11. THE DEVICE WAS RETURNED FOR INSPECTION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION IT IS LIKELY THAT THE EVENT REPORTED IS CAUSED DUE TO PUMP HEAD IS DAMAGED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE OLYMPUS FLUSHING PUMP EXHIBITED THICKNESS/MAGNITUDE NOT ADJUSTABLE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738493 FLUSHING PUMP OFP-2 (EU) OLYMPUS FLUSHING PUMP FEQ KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. K10001143

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown