BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUSHING PUMP OFP-2 (ROW)

    MDR report key: 19671231 · Received July 3, 2024

    Report

    Report Number
    9611174-2024-01289
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Report Date
    December 16, 2024
    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
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E2: HEALTH PROFESSIONAL ¿ (BLANK) AND E3: OCCUPATION ¿ NO INFORMATION PROVIDED. 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 REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. FOLLOWING FIELD WAS UPDATE: D8, G3, H2, H3, H4, H6, H11. A REVIEW OF 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. ACCORDING TO THE INVESTIGATION, ONLY THE REPORTED FAILURE MODES WAS DETECTED. BASED ON THE RESULTS OF THE INVESTIGATION, A PROBABLE ROOT CAUSE WAS COMPONENT FAILURE OF 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 HEAD WAS DETERIORATED. ACCORDING TO THE REPORT, WHEN THE PUMP HEAD PUMPED WATER, THE HEAD THAT PRESSED THE TUBE WAS RELEASED, AND WHEN WATER IS NEEDED, THE PUMP HEAD WAS LIFTED, AND THE PUMP HEAD THAT PRESSES THE TUBE WAS RELEASED. THE REPORTED ISSUE WAS FOUND DURING AN UNKNOWN PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473850 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