BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SE SINGLE CHANNEL PUMP

    MDR report key: 1031573 · Received April 18, 2008

    Report

    Report Number
    2016493-2008-00030
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    January 31, 2008
    Report Date
    March 20, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K931549
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION REQUESTED AND ALL AVAILABLE INFO IS INCLUDED.

    Description of Event or Problem · 1

    THE PT WAS RECEIVING AN INFUSION OF GLUCOSE. THE PT WAS CHECKED REGULARLY OVERNIGHT BY NURSING STAFF HOWEVER, AT 0600HRS, THE NURSE NOTED THAT THE PT'S ARM WAS SWOLLEN AND THE INFUSION HAD GONE "SUBCUTANEUS". THE PT'S NAILS WERE RED AND THE LOWER PART OF THEIR ARM WAS BLUE. THE INFUSION WAS STOPPED IMMEDIATELY. THE PT WAS REVIEWED BY A DOCTOR AND REQUIRED SURGERY. CARDINAL HEALTH HAS REQUESTED THAT THE PUMP IS RETURNED TO THE OFFICE FOR EXAMINATION AND TESTING; HOWEVER, THIS HAS NOT YET BEEN RECEIVED. AT PRESENT THERE IS NO INDICATION THAT THE PUMP WAS EITHER FAULTY OR MALFUNCTIONED. WHEN THE PUMP IS RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFO BECOMES AVAILABLE. CARDINAL HEALTH HAS RECENTLY RECEIVED A NUMBER OF REPORTS OF INFILTRATIONS/EXTRAVASATIONS FROM THIS HOSPITAL. LOCAL CARDINAL HEALTH STAFF HAVE ALREADY VISITED THE CUSTOMER TO PROVIDE FURTHER TRAINING ON THE USE OF THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE SINGLE CHANNEL PUMP FRN, INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 7131 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention