BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 6043657 · Received October 20, 2016

    Report

    Report Number
    6043657
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    April 27, 2016
    Report Date
    June 3, 2016
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALARIS PUMP MALFUNCTIONED TWICE WHILE TRANSPORTING AN UNSTABLE PATIENT TO THE OR. THE IV PUMP SHUT OFF WITHOUT NOTICE RESULTING IN PATIENT BECOMING HYPOTENSIVE DURING TRANSPORT. THE PT WAS PARALYZED, SEDATED AND INTUBATED, ALSO ON VASOPRESSORS AT MAX DOSE. THE ENTIRE PUMP SHUT OFF TWICE WHILE PATIENT BEING TRANSPORTED TO OR. THE PT'S BLOOD PRESSURE DROPPED WHILE THE NURSE REPROGRAMING PUMP. NO NOTICEABLE HARM TO PATIENT PRESENT AT THIS TIME. BIOMED REPAIRED PCU BRAIN, ALL OTHER DEVICES HAD NO PROBLEMS, RETURNED TO SERVICE. CE# 102944 PCU BRAIN - REPLACED FRONT/REAL PANEL, RIGHT/LEFT IUI CE# 102488 PCA - NO PROBLEM FOUND WITH DEVICE CE# 72325 MODULE - NO PROBLEM FOUND WITH DEVICE CE# 76750 MODULE - NO PROBLEM FOUND WITH DEVICE CE# 71066 MODULE - NO PROBLEM FOUND WITH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695092 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR