BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3063286 · Received February 26, 2013

    Report

    Report Number
    2016493-2013-00129
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Report Date
    January 29, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ONLY INFORMATION CURRENTLY AVAILABLE IS THE CUSTOMER'S STATEMENT "IT WAS INVOLVED IN AN OCCURRENCE WHERE THE END USER FEELS AN INCORRECT VOLUME WAS DELIVERED. THERE WASN'T ANY NEGATIVE OUTCOME TO THE PATIENT. WE CHECKED IT IN THE OFFICE AND THE UNIT APPEARS TO BE FUNCTIONING TO SPEC BUT WOULD LIKE A SECOND OPINION." NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT OR PATIENT INFORMATION PROVIDED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81933 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

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