BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3717809 · Received February 26, 2014

    Report

    Report Number
    2016493-2014-00100
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    December 4, 2013
    Report Date
    January 7, 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
    SD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICES RECEIVED, LOG REVIEW ONLY. THE CUSTOMER'S REPORT OF AN OVER INFUSION WAS VERIFIED VIA AN EVENT LOG REVIEW. ON (B)(6) 2013 AT 4:53 AM THE INFUSION WAS STARTED WITH RATE OF 65ML/HR. AT 6:07AM THE RATE WAS CHANGED TO 200ML/HR. AT 6:23 AM THE INFUSION COMPLETED AND AT 6:24 THE RATE WAS CHANGED FORM 200ML/HR TO 65ML/HR. AT 6:37 AM THE VOLUME INFUSED OF 65.819ML WAS CLEARED AND AT 7:54 AM THE VOLUME TO BE INFUSED WAS CHANGED TO 200 ML. THE ROOT CAUSE WAS IDENTIFIED AS USER PROGRAMMING; NO DEVICE MALFUNCTION WAS SUSPECTED TO HAVE OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED IN THE PEDIATRIC ICU ON (B)(6) 2013 AT 0500 THE RATE WAS SET FOR 65ML/HR WITH A VOLUME OF 130ML. AT APPROXIMATELY 0620 THE NURSE NOTICED THE RATE CHANGED TO 200ML/HR. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117585 ALARIS PUMP MODULE FRN CARDINAL HEALTH 303, INC. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE, SN:(B)(4)| ALARIS PC UNIT, SN: (B)(4)| ALARIS SYRINGE MODULE, SN: (B)(4)| ALARIS PUMP MODULE ADMIN SET, MODEL/LOT # UNK