BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 1692348 · Received May 13, 2010

    Report

    Report Number
    2016493-2010-00436
    Event Type
    Injury
    Date Received
    May 13, 2010
    Date of Event
    January 16, 2010
    Report Date
    April 13, 2010
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). EVENT LOGS HAVE BEEN REC'D FOR ANALYSIS. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION FINDINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TPN INFUSING AT 2 CC/H THROUGH ALARIS PUMP. GRADUAL INCREASE OF OXYGEN AS WELL AS VENTILATORY NEEDS WERE REQUIRED THROUGHOUT THE EVENING. THE PT HAD TWO EPISODES OF HYPERGLYCEMIA. AT 0630, THE BEDSIDE RN NOTED THAT THE ENTIRE BAG OF TPN OF 183 CC WAS EMPTY. ALTHOUGH REQUESTED, NO ADD'L INFO HAS BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Required Intervention ALARIS PC UNIT: (B) (4)