BEUDAMED
    FDA Adverse Event Other Summary report: N

    MODEL 6301

    MDR report key: 512406 · Received February 23, 2004

    Report

    Report Number
    512406
    Event Type
    Other
    Date Received
    February 23, 2004
    Date of Event
    July 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 100ML BAG OF MILRINONE LACTATE FOUND EMPTY AFTER RUNNING FOR ABOUT 2 HRS AND 50 MINS. PUMP SET AT INFUSION RATE OF 10.9ML/HR AND SHOULD HAVE INFUSED OVER A 6 HOUR PERIOD. 1) INFUSION BEGAN. 2) RATE SET AT 10.9ML/HR. 3) AIR-IN-LINE ALARM SOUNDED AND BAG FOUND EMPTY (2 HRS 50 MIN LATER). 4) PUMP READING WAS 59.4ML REMAINING TO BE INFUSED. 5) IV DISCONTINUED. UPON INSPECTION BY BIO-MED, UPON OPENING THE "FRONT DOOR" OF THE PUMP APPROX 3/4 OF AN INCH OF IV TUBING WAS FOUND TO BE SLACK OVER THE PERISTALTIC MECHANISM. AFTER COMPLETE DIAGNOSTIC TESTING NO DEFECTS WERE FOUND. IT IS CRITICALLY IMPORTANT THAT ALL SLACK BE REMOVED FROM THE TUBING WHEN BEING LOADED OVER THE PERISTALTIC FLOW MECHANISM. THE PUMP WAS FOUND TO BE OPERATING SATISFACTORALY AND WAS RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 6301 PUMP, INFUSION FRN BAXTER HEALTHCARE CORP. MODEL 6301 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *