BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3821561 · Received January 15, 2014

    Report

    Report Number
    2016493-2014-00066
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Date of Event
    December 30, 2013
    Report Date
    January 3, 2014
    Manufacturer
    CARDINAL HEALTH 303, INC.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REPORT DATE: 11/15/2014. INTERNAL FILE NO: (B)(4). THE CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW. THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INFUSION OF RITUXIMAB WAS INTENDED TO RUN OVER ONE HOUR, INSTEAD THE INFUSION LASTED FOR APPROXIMATELY 3 HOURS. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. NO FURTHER PT/EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41039 ALARIS PUMP MODULE FRN CARDINAL HEALTH 303, INC. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SN UNK| ALARIS PUMP MODULE ADMIN SET, MODEL/LOT UNK