BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS INFUSION PUMP - LARGE VOLUME MODULE

    MDR report key: 2081814 · Received May 3, 2011

    Report

    Report Number
    MW5020494
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 29, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FRN
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ALARIS PUMP PROGRAMMED FOR VANCOMYCIN 1000 MG / 250 ML TO INFUSE OVER 1 HR. MEDICATION INFUSED IN 22 MINUTES. PUMP SHOWED "173.2 ML VTBI" AND "TIME LEFT: 41 MINUTES" WHEN EVENT OCCURRED. PT'S FACE FLUSHED WITH SHALLOW RESPIRATIONS. SOLUMEDROL IV ADMINISTERED. REACTION RESOLVED AND PT REMAINED ON NURSING UNIT. BIOMED NOTIFIED AND INFUSION PUMP REMOVED FROM SERVICE. MEDWATCH REPORT SUBMITTED TO MANUFACTURER. PUMP SENT TO MANUFACTURER FOR INCIDENT EVALUATION BECAUSE BIOMED WAS UNABLE TO REPRODUCE PUMP MALFUNCTION AND PUMP PASSED ALL PERFORMANCE TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION PUMP - LARGE VOLUME MODULE FRN CARDINAL HEALTH 10011324

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention