BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SE INFUSION PUMP

    MDR report key: 1881088 · Received October 20, 2010

    Report

    Report Number
    2016493-2010-00472
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 21, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K931550
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRIMARY AND SECONDARY ADMINISTRATIONS SETS USED WERE NOT SAVED. DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER MEDWATCH (NO REPORT NUMBER PROVIDED) REPORTED SECONDARY INFUSION OF DILANTIN, 170ML WAS TO INFUSE AT 170ML/HR. THE ENTIRE 170ML VOLUME INFUSED OVER 5 MINUTES, RATHER THAN ONE HOUR. THE PUMP SETTINGS WERE VERIFIED AND READ RATE AT 170ML AND VOLUME LEFT TO BE INFUSED 148ML. DILANTIN 1 GRAM IN 150ML NORMAL SALINE (TOTAL VOLUME 170ML). CUSTOMER REPORTED ICU PATIENT'S BLOOD PRESSURE (BP) DROPPED FROM 114/68 TO 64/49. PATIENT WAS GIVEN IV BOLUS (AMOUNT UNKNOWN) OF LACTATED RINGER'S AND BP RETURNED TO BASELINE IN 10-15 MINUTES. AS OF (B)(6) 2010 PATIENT WAS OUT OF ICU BUT STILL HOSPITALIZED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE INFUSION PUMP FRN CAREFUSION CORPORATION 7200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention