BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLUMETRIC INFUSION PUMP

    MDR report key: 10884674 · Received November 20, 2020

    Report

    Report Number
    MW5098013
    Event Type
    Injury
    Date Received
    November 20, 2020
    Date of Event
    November 4, 2020
    Report Date
    November 18, 2020
    Manufacturer
    ZYNO MEDICAL LLC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE NURSE CARING FOR THE PATIENT WENT TO CHECK BECAUSE SHE HAD NOT HEARD IT ALARM TO FIND AIR IN THE LINE. IV PUMP HAD BEEN INFUSING AND WHEN IT WAS COMPLETE, IT DID NOT ALARM. AIR WAS IN LINE AND WAS ALL THE WAY TO THE PATIENT. IT WAS UNKNOWN HOW MUCH AIR THE PATIENT RECEIVED. PHYSICIAN EXAMINED PATIENT AND PATIENT WAS DISCHARGED HOME WITHOUT ANY ADVERSE EFFECT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345641 VOLUMETRIC INFUSION PUMP PUMP, INFUSION FRN ZYNO MEDICAL LLC. Z-800WF SN 5000018

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention