BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUSHING PUMP OFP-2 (EU)

    MDR report key: 20193048 · Received September 11, 2024

    Report

    Report Number
    9611174-2024-01503
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Report Date
    October 8, 2024
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    FEQ
    PMA / PMN Number
    K100899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E2/E3: NO INFORMATION AVAILABLE FOR THE OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE CORRECTION OF THE REPORTABILITY OF THE MALFUNCTION REPORTED IN THE INITIAL EMDR AND THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: D8, H4, H6, H11. AN OLYMPUS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE USER FACILITY AND CONFIRMED THE REPORTED ¿INSUFFICIENT PRESSURE¿. THE CAUSE WAS A FAULTY/DAMAGED/WORN PUMP HEAD. BASED ON THE RESULTS OF THE INVESTIGATION AND INFORMATION OBTAINED FROM THIS COMPLAINT, THE MOST PROBABLE CAUSE OF THE COMPLAINT WAS TRACED TO COMPONENT FAILURE, WHICH IS EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. THE REPORTED EVENT WAS SENT IN ERROR AND WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF IF WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE SUBJECT DEVICE HAD INSUFFICIENT PRESSURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE SUBJECT DEVICE HAD INSUFFICIENT PRESSURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506180 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