BEUDAMED
    FDA Adverse Event Death Summary report: N

    3M

    MDR report key: 5072012 · Received December 23, 2004

    Report

    Report Number
    5072012
    Event Type
    Death
    Date Received
    December 23, 2004
    Date of Event
    November 30, 2001
    Report Date
    December 20, 2004
    Manufacturer
    SMITH'S MEDICAL MD, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    ONE GM OF VANCOMYCIN ORDERED AND STARTED VIA AVI INFUSION PUMP. IT WAS TO INFUSE OVER 1 HR INFUSION PUMP. IT WAS TO INFUSE OVER 1 HR FOR A TOTAL OF 150CC. APPROX 15 MINS INTO INFUSING, THE PATIENT WENT INTO DISTRESS (PALE AND UNRESPONSIVE). A 911 CALL LOOKED UP AT IV BAG AND NOTED THAT VANCO BAG WAS EMPTY. PUMP READ 47CC INFUSED. PT WAS GIVEN 300 NS PLACED IN OXYGEN WITH GOOD RESPONSE, ALERT WITH EVEN RESPIRATION HAD NAUSEA, VOMITING. APPROX 5 MINUTES LATER, PT AGAIN BECAME UNRESPONSIVE WITH SNORING RESPIRATIONS PULSE WEAK, 911 RESPONDED AT THIS POINT. PT WENT IN VENTRICULAR FIB. CPR PERFORMED. PT PRONOUNCED AT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M IV ADMINISTRATION SET FPA SMITH'S MEDICAL MD, INC. 21-0324-01 APR 04T16

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death