BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUSHING PUMP OFP-2 (EU)

    MDR report key: 19719560 · Received July 11, 2024

    Report

    Report Number
    9611174-2024-01316
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 11, 2024
    Report Date
    September 10, 2024
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    FEQ
    PMA / PMN Number
    K100899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND A CORRECTION TO THE FOLLOWING FIELD(S): D8, D10, G3, H4, H6 AND H11. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUE IS EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. 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 FLUSHING PUMP HAD FAILURE AT THE PUMP HEAD. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FLUSHING PUMP HAD FAILURE AT THE PUMP HEAD. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235857 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