BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVI INFUSION PUMP

    MDR report key: 83333 · Received July 1, 1996

    Report

    Report Number
    83333
    Event Type
    Injury
    Date Received
    July 1, 1996
    Date of Event
    April 17, 1996
    Report Date
    April 24, 1996
    Manufacturer
    3M HEALTH CARE DIV. AVI INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE AND PT (WHO IS ALSO AN RN) CONFIRM INFUSION PUMP SET AT 14CC/HR. 4 HOURS LATER, ENTIRE 25,000 U OF HEPARIN INFUSED, AND WHEN PUMP CHECKED, RATE AT 125CC AND VOL. AT 800CC. STAFF AND PT DENY HAVING RE-SET UNIT. PTT GREATER THAN 120. PROTAMINE SULFATE GIVEN. NO COMPLICATIONS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVI INFUSION PUMP INFUSION PUMP FRN 3M HEALTH CARE DIV. AVI INC. 200A *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R