BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS INFUSER PUMP

    MDR report key: 11920914 · Received June 1, 2021

    Report

    Report Number
    MW5101645
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    May 21, 2021
    Report Date
    May 27, 2021
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EQUIPMENT MALFUNCTION THE HC-8032B ALARIS INFUSER LED TO MEDICATION OVERDOSE. FOUND THAT THERE IS A BROKEN BEZEL MEMBRANE FRAME ASSEMBLY PART# TC10006587. THIS BROKEN PIECE CAN ALLOW FOR THE DOOR TO BE CLOSED AND IV FLUIDS TO FREE FLOW. RECALL ALERT RECEIVED IN JUNE 2020 WITH PM PERFORMED ON THIS DEVICE SPT. 2020 WITHOUT ANY ISSUES. PUMP HAS BEEN SEQUESTERED AND IS BEING SENT TO MANUFACTURER. DURING PROCEDURE, ANESTHESIOLOGIST DISCOVERED A PUMP MALFUNCTION DURING THE PHENYLEPHRINE INFUSION WHICH WAS RUNNING FREE FLOW. IMMEDIATE RESPONSE AND TREATMENT TO BP INCREASE WITH SUCCESSFUL RESPONSE IN PATIENT CONDITION. PROCEDURE CONTINUED WITH STABLE BP. AT THE COMPLETION OF THE CASE AFTER THE DRAPES WERE REMOVED, THE PATIENT'S LEFT EYE APPEARED DILATED AND FIXED, PATIENT WENT INTO CARDIAC ARREST. A CODE WAS CALLED, AND CPR WAS INITIATED. SUCCESSFUL ROSC AND PATIENT WAS TRANSFERRED TO ICU IN CRITICAL CONDITION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807581 ALARIS INFUSER PUMP PUMP, INFUSION FRN CAREFUSION 303, INC. HC-8032B ALARIS INFUSER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R| S