BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 3004003 · Received November 6, 2008

    Report

    Report Number
    2016493-2008-00167
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 11, 2008
    Report Date
    October 14, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INSULIN WAS SUPPOSED TO BE INFUSING AT 3 UNITS PER HOUR AND WAS FOUND TO BE RUNNING AT 30 UNITS PER HOUR. THE BAG CONCENTRATION WAS 1 UNIT/ML (100 UNITS IN 100 ML). PT RECEIVED CONCENTRATED DEXTROSE FOR REVERSAL OF PROFOUND HYPOGLYCEMIA (DOSES AND LAB VALUES NOT PROVIDED), SUBSEQUENTLY RECOVERED WITHOUT ADVERSE CONSEQUENCES. SYSTEM LOG AND DATASET HAVE BEEN RECEIVED, INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PUMP MODULE FRN, INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ALARIS PUMP MODULE: SERIAL NUMBER (B)(4)| ALARIS PC UNIT: SERIAL NUMBER (B)(4)