BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUSHING PUMP OFP-2 (ROW)

    MDR report key: 24716286 · Received March 30, 2026

    Report

    Report Number
    9611174-2026-00068
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 27, 2026
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    FEQ
    UDI-DI
    15019778003238
    PMA / PMN Number
    K100899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION A ROOT CAUSE COULD NOT BE IDENTIFIED. IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: COMPONENT FAILURE OF THE PUMP HEAD. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OLYMPUS FLUSHING PUMP WAS FOUND TO HAVE A FLOW RATE OUTSIDE THE STANDARD RANGE DURING PRE-USE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771943 FLUSHING PUMP OFP-2 (ROW) OLYMPUS FLUSHING PUMP FEQ KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. K10001145 15019778003238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown