BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLO GARD 6301 BY TRAVENOL

    MDR report key: 87159 · Received April 25, 1997

    Report

    Report Number
    87159
    Event Type
    Injury
    Date Received
    April 25, 1997
    Date of Event
    November 6, 1996
    Report Date
    March 15, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PUMP 2 OF THIS DUAL CHANNEL PUMP. PT RETURNED FROM CATH LAB AND IV FLUIDS HAD NOT INFUSED. PUMP WITH NO ALARMS NOTED. IV CLAIM APPROPRIATE FOR VOLUME TO BE INFUSED, BUT BAG WAS STILL FULL. MEDICATION TO HAVE BEEN INFUSED WAS REO-PRO. HEPARIN BOLUS GIVEN AND REO-PRO STARTED. NEW IV SET AND NEW PUMP. PT HAD CHEST PAIN AND WAS RETURNED TO CATH LAB SAME DAY. PT AT HIGH RISK FOR CLOSURE OF THE ARTERY BEFORE THE REO PRO STARTED. PTCA PERFORMED. IV NITROGLYCERIN INFUSING; STENT LATER PLACED. DISCHARGED 11/8/96 IN GOOD CONDITION. BIOMED CHECKED PUMP ON 11/7/96 AND FOUND NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO GARD 6301 BY TRAVENOL INFUSION-PUMP DUAL CHANNEL FRN BAXTER HEALTHCARE CORP. 6301 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention