BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 19009163 · Received March 30, 2024

    Report

    Report Number
    3006575795-2024-00097
    Event Type
    Malfunction
    Date Received
    March 30, 2024
    Date of Event
    March 22, 2024
    Report Date
    March 30, 2024
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00814371020013
    PMA / PMN Number
    K130690
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6)2024 FLOWRATE ISSUE WAS OBSERVED DURING PREVENTIVE MAINTENANCE/CALIBRATION WITHIN ZYNO MEDICAL, LLC. CAUSE NOT 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(B)(6)2024, DURING SERVICING ACTIVITIES OF ZYNO MEDICAL DEVICES WHICH INCLUDES PREVENTIVE MAINTENANCE, THERE IS AN FLOWRATE ISSUE OBSERVED WHERE FLOW RATE OFFSET% AT PRE-REWORK IS 5% AND FLOWRATE OFFSET% AT POST-REWORK IS 0%. THIS ISSUE IS DETERMINED TO BE A FLOWRATE UNKNOWN ISSUE. NO PATIENT INVOLVED AS THIS IS OBSERVED DURING CALIBRATION/ PREVENTIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2388032 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z800F 20160517-SH 00814371020013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown