BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYNO PUMP

    MDR report key: 18537729 · Received January 17, 2024

    Report

    Report Number
    MW5150519
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    January 12, 2024
    Report Date
    January 15, 2024
    Manufacturer
    ZYNO MEDICAL LLC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    117
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS HAVING AVSOLA INFUSED VIA ZYNO PUMP AS A RAPID PROTOCOL, AT THE FINAL INFUSION RATE OF 500 ML/HR, THE NURSE NOTICED THE PUMP WAS NOT ALARMING AND MANUALLY STOPPED THE INFUSION AFTER SHE NOTICED THE LINE WAS EMPTY/AIR IN LINE AFTER THE FLUID HAS PASSED THE PUMP. THE AIR-IN LINE DID NOT REACH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404026 ZYNO PUMP SET, ADMINISTRATION, INTRAVASCULAR FPA ZYNO MEDICAL LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male Required Intervention