BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLO-GARD 6301 DUAL CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 87171 · Received April 25, 1997

    Report

    Report Number
    6000001-1997-00541
    Event Type
    Injury
    Date Received
    April 25, 1997
    Date of Event
    November 6, 1996
    Report Date
    March 27, 1997
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT RETURNED FROM THE CATH LAB WITH "REO-PRO" TO BE INFUSING THROUGH CHANNEL TWO OF THE PUMP. HOWEVER, IT WAS DISCOVERED THAT THE APPEARED TO BE OPERATING, BUT THE SOLUTION CONTAINER REMAINED FULL. A BOLUS OF HEPARIN WAS GIVEN AND "REO-PRO" WAS RESTARTED USING A DIFFERENT INFUSION PUMP AND IV SET. THE PT COMPLAINT OF CHEST PAIN AND WAS RETURNED TO THE CATH LAB THE SAME DAY. IT WAS COMMENTED THAT THE PT WAS AT HIGH RISK OF CLOSURE OF THE CORONARY ARTERY BEFORE THE INITIAL INFUSION OF REO-PRO WAS STARTED. THE PT UNDERWENT PTCA, NTG STARTED, AND A STENT WAS LATER PLACED. THE PT WAS DISCHARGED TWO DAYS LATER IN "GOOD CONDITION." THE REPORTER STATED THAT DUE TO THE PT'S CONDITION PRIOR TO THE INFUSION BEING STARTED IT IS DIFFICULT TO DETERMINE IF THE REPORTED OCCURRENCE CONTRIBUTED TO THE NEED FOR PTCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6301 DUAL CHANNEL VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. 6302 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR