BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYNO Z-800F

    MDR report key: 23757397 · Received December 9, 2025

    Report

    Report Number
    MW5180168
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    December 1, 2025
    Report Date
    December 3, 2025
    Manufacturer
    ZYNO MEDICAL LLC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    117
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT RECEIVING IVIG (INTRAVENOUS IMMUNOGLOBULIN) CAME OUT OF ROOM ENDORSING SOB (SHORTNESS OF BREATH), HE STATED THAT IT FELT LIKE HE COULD NOT TAKE A FULL BREATH AND HAD CHEST PRESSURE. RN (REGISTERED NURSE) OBSERVED THAT HIS 2ND BOTTLE OF IVIG WAS EMPTY AND NOTED THAT THE PUMP WAS STILL GOING, IT DID NOT ALARM TO ALERT STAFF OF AIR IN LINE. UPON INSPECTION OF THE TUBING, IT WAS NOTED THAT THERE WAS NO FLUID IN THE LINE. THE PUMP (ZYNO Z-800F SERIAL NUMBER (B)(6)) WAS IMMEDIATELY STOPPED AND DISCONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990389 ZYNO Z-800F PUMP, INFUSION FRN ZYNO MEDICAL LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Hospitalization| L INTRAVENOUS IMMUNOGLOBULIN.