BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 8821935 · Received July 24, 2019

    Report

    Report Number
    9616066-2019-02091
    Event Type
    Injury
    Date Received
    July 24, 2019
    Report Date
    June 27, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT SEQUESTERED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED. REQUESTED PATIENT DEMOGRAPHICS HOWEVER NOT PROVIDED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VERSED AND INSULIN WERE INFUSING AT UNSPECIFIED RATES WHEN THE USER ACCIDENTLY CROSSED THE LINES AND PROGRAMMED THE INCORRECT RATE. THE PATIENT EXPERIENCED HYPOGLYCEMIA DUE THE EVENT. THE FACILITY PHARMACIST IS REQUESTING BEST OF PRACTICE FOR LABELING IV LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614063 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION PRI TUBING

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (2)8100,8015,PRI TUBING, TD UNK