BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODY GUARD 323 INFUSING PUMPS

    MDR report key: 6155938 · Received December 8, 2016

    Report

    Report Number
    6155938
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    October 20, 2016
    Report Date
    November 7, 2016
    Manufacturer
    CME AMERICA
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CHEMOTHERAPY AGENT THAT SHOULD HAVE INFUSED AT 13.3 ML/HR OVER 48 HOURS WAS INFUSED AT 641 ML/HR, LESS THAN 2 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804644 BODY GUARD 323 INFUSING PUMPS BODY GUARD 323 INFUSING PUMPS FPA CME AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R