BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 18992045 · Received March 28, 2024

    Report

    Report Number
    3006575795-2024-00092
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    March 18, 2024
    Report Date
    March 27, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 3/18/2024 FLOWRATE ISSUE WAS REPORTED WITHIN ZYNO MEDICAL, LLC WHICH WAS OBSERVED DURING CALIBARATION/ PREVENTIVE MAINTENANCE. THERE IS NO SPECIFIC CAUSE ESTABLISHED. A CAPA HAS BEEN OPENED IN ORDER TO FULLY DIAGNOSE AND ADDRESS THE ROOT CAUSE OF THE REPORTED EVENT. AS THIS IS OBSERVED DURING PREVENTIVE MAINTENANCE, ALL THE ISSSUES WITHIN THE PUMP WERE RESOLVED.

    Description of Event or Problem · 0

    ON 03/18/2024, ZYNO TECHNICIAN REPORTED AN ISSUE WITHIN ZYNO, LLC WHICH IS TAKEN AS AN COMPLAINT THAT THERE WAS A FLOW RATE ISSUE OBSERVED DURING PREVENTIVE MAINTENACE/ CALIBRATION WHERE FLOW RATE OFFSET% AT PRE-REWORK IS 6% AND FLOW RATE OFFET% AT POST-REWORK IS -1% . THIS IS DETERMINED TO BE A FLOWRATE UNKOWN ISSUE. NO PATIENT INVOLVED AS THIS IS OBSERVED DURING CALIBRATION/PREVENTIVE MAINTENANCE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719440 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z800F 20160111-SH 00814371020013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown