BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER HEALTHCARE CORP

    MDR report key: 311103 · Received January 4, 2001

    Report

    Report Number
    MW1020753
    Event Type
    Injury
    Date Received
    January 4, 2001
    Date of Event
    December 6, 2000
    Report Date
    December 22, 2000
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT 7 PM A HEPARIN INFUSION WAS INITIATED UTILIZING A BAXTER IV INFUSION PUMP AND BAXTER TUBING. THE PUMP WAS SET FOR 20CC/HR. AT 10:30 PM THE EVENING NURSE CLEARED THE PUMP FOR THE AMOUNT INFUSED ON HER SHIFT (67CC). AT 12 MIDNIGHT THE IV WAS CHECKED BY THE NIGHT NURSE, AND SHOWED 385 CC LEFT TO BE INFUSED: THE PUMP WAS STILL SET AT 20 CC/HR. AT 1 AM THE NURSE ENTERED THE ROOM AND FOUND THE BAG EMPTY. THE PUMP SHOWED 43 CC HAD INFUSED SINCE IT WAS LAST CLEARED; IT ALSO SHOWED 365 CC LEFT TO BE INFUSED. THE TUBING AND PUMP WERE BOTH SEQUESTERED. BIOMED EVALUATED THE PUMP AND COULD NOT FIND A PROBLEM. THE TUBING WAS NOTED TO HAVE A SEVEN INCH SECTION THAT WAS FLATTENED. THE HEPARIN INFUSION WAS HELD AND THEN RESTARTED THE NEXT DAY ON PT 20CC/HR AT 5PM. THREE DAYS LATER THE PT DEVELOPED AN INTRACRANIAL BLEED THAT REQUIRED SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217 BAXTER HEALTHCARE CORP BAXTER INFUSION PUMP FRN BAXTER HEALTHCARE CORP 6201 *
    278 BAXTER HEALTHCARE CORP INFUSION ADMINISTRATION SET FPA BAXTER HEALTHCARE CORP. CONTINU-FLO 2C6537S

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention BAXTER CONTINU-FLO INFUSION ADMIN SET.