BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 25044730 · Received April 30, 2026

    Report

    Report Number
    MW5187476
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 25, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ZYNO MEDICAL LLC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER EXPLAINED THAT THEIR INFUSION ALARM DIDN'T GO OFF. WOKE UP WITH CHEST PAINS AFTER FALLING ASLEEP WHILE BEING INFUSED AND WENT TO THE EMERGENCY ROOM. PUMP WAS GIVEN TO REPORTER ON (B)(6) 2026. Z800F ZYNO INFUSION PUMP RECALLED 06-16-2025 DUE TO AIR IN LINE SOFTWARE DEFECT. THIS IS THE 3RD PUMP THAT HAS MALFUNCTIONED. REPORTER STATED THAT THE HOME HEALTH PHARMACY DID NOT INFORM THEM THAT PUMP WAS RECALLED. PER REPORTER, THE PHARMACY GAVE THEM A NEW BRAND OF DEVICE WITH MISSING PARTS AND TOLD REPORTER TO CONTINUE USING OLD PUMP UNTIL ALL THE NEW PIECES WERE PROVIDED. PT: 1776. DEVICE: 2880, 4062, 1019. REFERENCE: MW5187474, MW5187475.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373614 INFUSION PUMP PUMP, INFUSION FRN ZYNO MEDICAL LLC. Z800F

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization