BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3983188 · Received June 27, 2014

    Report

    Report Number
    2016493-2014-00307
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 9, 2014
    Manufacturer
    CAREFUSION CORP.
    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

    (B)(4). THE CUSTOMER'S COMPLAINT OF AN INFUSION RUNNING FASTER THAN EXPECTED COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE CUSTOMER DID NOT RECORD THE DEVICE SERIAL NUMBER, THEREFORE, NO FAILURE INVESTIGATION COULD BE PERFORMED. NO PRODUCT RETURN IS EXPECTED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 800-1000ML OF A PRIMARY RITUXAN INFUSION BAG WAS FOUND EMPTY AFTER 30 MINUTES. THE SET UP INCLUDED A NORMAL SALINE INFUSION CONNECTED TO THE VENOUS ACCESS AND THE RITUXAN CONNECTED TO THE MOST DISTAL PORT ON THE NORMAL SALINE LINE. BASIC INFUSION PROGRAMMING WAS USED FOR THIS INFUSION. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377801 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORP. 8100 NA

    Patients

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