BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUSHING PUMP OFP-2 (JP)

    MDR report key: 20001888 · Received August 20, 2024

    Report

    Report Number
    9611174-2024-01436
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    August 9, 2024
    Report Date
    September 30, 2024
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    FEQ
    PMA / PMN Number
    K100899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 EVALUATION OF THE EVENT 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 LEGAL MANUFACTURER'S FINAL INVESTIGATION RESULTS AND ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER. REVIEWING THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: THE FLOW RATE CONTROLS BUTTON DID NOT RESPOND, AND THE POWER INDICATOR DID NOT ILLUMINATE. BASED ON THE INVESTIGATION'S RESULTS, IT IS LIKELY THAT THE FOLLOWING LED TO THE MALFUNCTION: THIS EVENT WAS CAUSED BY A COMPONENT FAILURE OF THE CONTROL PANEL. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BUTTON ON THE FLUSHING PUMP DID NOT WORK AS INTENDED. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BUTTON ON THE FLUSHING PUMP DID NOT WORK AS INTENDED. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209838 FLUSHING PUMP OFP-2 (JP) OLYMPUS FLUSHING PUMP FEQ KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. K10001142

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown