BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 19752487 · Received July 16, 2024

    Report

    Report Number
    3006575795-2024-00561
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    July 10, 2024
    Report Date
    July 16, 2024
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00814371020013
    PMA / PMN Number
    : K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE ARE PREVIOUS COMPLAINTS (B)(4) ON THE DEVICE. HISTORICAL RECORDS WERE REVIEWED. IT WAS DISCOVERED THAT THERE WERE DISCREPANCIES IN THE TEST RECORDS. NCR #2024-018 HAD BEEN INITIATED TO ADDRESS THE DISCREPANCIES. THIS PUMP UNDERWENT ROUTINE MAINTENANCE TESTING WHERE IT WAS DETECTED THE PUMP'S PERFORMANCE FELL OUTSIDE THE ACCEPTABLE RANGE FOR THE FLOWRATE %. CONSEQUENTLY, IT NECESSITATED AN ADJUSTMENT TO THE PUMP'S FLOWRATE %. IT WAS CONFIRMED THE RECALIBRATION ADDRESSED THE ISSUE SUCCESSFULLY. A CAPA HAS BEEN OPENED IN ORDER TO FULLY INVESTIGATE AND ADDRESS THE ROOT CAUSE OF THE REPORTED EVENT. REFERENCE TO COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    ON 07/12/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE DEVICE WAS REPORTED TO HAVE A FLOW RATE OFFSET ISSUE. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2523992 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z800F 160802700 00814371020013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown