BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2902041 · Received November 28, 2012

    Report

    Report Number
    2016493-2012-00504
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REQUESTED AN EVENT LOG REVIEW. THE EVENT LOGS AND DATA SET HAVE NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE CUSTOMER PROVIDE THE DATA SET AND EVENT LOGS FOR EVALUATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE PUMP WAS SET TO DELIVER AN INFUSION OVER ONE HOUR AND THE FLUID BOTTLE WAS EMPTY IN 15 MINUTES. NO PT HARM OR MEDICAL INTERVENTION REPORTED. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE ADMINISTRATION SET:| ALARIS PC UNIT: SN UNKNOWN| MODEL/LOT UNKNOWN