BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2981085 · Received February 20, 2013

    Report

    Report Number
    2016493-2013-00106
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 26, 2013
    Report Date
    January 29, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES NOT RECEIVED, LOT REVIEW ONLY. THE CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW. THE EVENT LOGS AND DATA SET HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN OVER INFUSION OF HEPARIN. THE INFUSION WAS STARTED AT 2:40PM AND WITHIN AN HOUR THE ENTIRE BAG OF 250MLS INFUSED. THE HEPARIN CONCENTRATION WAS 100 UNITS/ML AND WAS PROGRAMMED TO RUN AT 12ML/HR. THE PROGRAMMING WAS DOUBLE CHECKED BY MORE THAN TWO NURSES BEFORE THE INFUSION WAS STARTED AND AFTER THE EVENT WAS IDENTIFIED. THE PATIENT WAS GIVEN A TOTAL OF 100MG PROTAMINE AND A CT SCAN OF THE BRAIN WAS PERFORMED. THE PATIENT DID NOT DEVELOP ANY BLEEDING. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL PATIENT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74053 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention ALARIS PC UNIT: SN (B)(4)| MODEL/LOT UNKNOWN| ALARIS PUMP MODULE ADMINISTRATION SET: