BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUSHING PUMP OFP-2 (ROW)

    MDR report key: 20313683 · Received September 26, 2024

    Report

    Report Number
    9611174-2024-01560
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 17, 2024
    Report Date
    December 11, 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
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: D8, D9, H3, H4, H6 AND H11. THE DEVICE WAS RETURNED TO THE REGIONAL REPAIR CENTER FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, 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 FLUSHING PUMP WAS NOT WORKING PROPERLY AND HAD UNSATISFACTORY FLOW. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE FLUSHING PUMP WAS NOT WORKING PROPERLY AND HAD UNSATISFACTORY FLOW. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434305 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