BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 11027143 · Received December 17, 2020

    Report

    Report Number
    11027143
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 23, 2020
    Report Date
    November 25, 2020
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ALARIS PUMP INFUSING SECONDARY BAG BACKWARDS INTO PRIMARY BAG. DIFFICULT TO TELL HOW MUCH MEDICATION WENT TO THE PATIENT. CAN SEE THE SECONDARY INFUSING INTO PRIMARY BAG. THE CHANNEL THAT WAS RUNNING THE PROGRAM INCORRECTLY WAS LABELED TKO2. I AM INCLUDING A PICTURE OF THE SET UP AND INFO PROVIDED BY BIOMED. IV PRIMARY AND SECONDARY TUBING APPEARED TO BE SET UP CORRECTLY WHEN VISUALIZED. BIO - BD CAREFUSION, ALARIS PUMP 8100 (ASSET# 3000-10668), SN (B)(4), REF 8100DXEN91177, TK01 - BD CAREFUSION, ALARIS PUMP 8100 (ASSET# 3000-70013), SN (B)(4), REF 8100BDNDXEN933, PCU - BD CAREFUSION, ALARIS PCU 8015 (ASSET# 3000-70242), SN (B)(4), REF 8015BDNDXEN9331, TK02 - BD CAREFUSION, ALARIS PUMP 8100 (ASSET# 3000-25467), SN (B)(4), REF 8100ADXEN917.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493661 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA