BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1231307 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88385
    Event Type
    Injury
    Date Received
    November 17, 2008
    Date of Event
    May 11, 2007
    Report Date
    May 18, 2007
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF FREE FLOW COULD NOT BE CONFIRMED AND COULD NOT BE DUPLICATED DURING SERVICE. A REVIEW OF THE ALARM LOG SHOWS THAT THERE IS NO FAILURE CODE, JUST ALARM. NO PROGRAMMING FOUND IN THE PUMPS MEMORY (ALL ZEROS). ACCURACY TEST WERE PERFORMED AND ALL VALUES ARE WITHIN SPECIFICATION. CHECKED UNCONTROLLED FLOW ALONG THE LENGTH OF TUBING WITH THE SLIDE CLAMP ENGAGED OUT SIDE THE PUMP AND AGAIN INSTALLED IN THE PUMP WITH ROTATE 90 DEGREES ENGAGED. NO UNCONTROLLED FLOW WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF OVER INFUSION WAS NOT CONFIRMED AND COULD NOT BE DUPLICATED DURING SERVICE. THE PUMP PASSED THE POWER ON SELF-TEST ON AC. THE PUMP WAS TESTED FOR ACCURACY AND FOUND TO BE WITHIN SPECIFICATION. INSPECTION OF THE PUMP HEAD FOUND NO DAMAGE OR DEFECT. THE KEYPAD WAS TESTED FOR PROPER OPERATION AND ALL KEYS WERE FOUND TO FUNCTION PROPERLY. VISUAL INSPECTION OF PUMP HEAD FOUND NO DAMAGE OR DEFECT. NO UNCONTROLLED FLOW WAS OBSERVED. ACCURACY TESTS WERE PERFORMED AND ALL VALUES ARE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FREE FLOW OF PITOCIN DURING PATIENT USE. PITOCIN 30 MILLIUNTS IN 500ML OF NORMAL SALINE WAS HUNG AT 0648 IN 2007. THE PUMP WAS PROGRAMMED AT A RATE OF 4 MILLUNITS/HOUR. A LITER OF LACTATED RINGER SOLUTION WAS BEING INFUSED AT 125 ML/HOUR VIA GRAVITY. AT 0649 THE NURSE NOTICED THAT THE DROPS WERE MOVING TOO FAST, AND THE PITOCIN INFUSION WAS IMMEDIATELY STOPPED. THE PATIENT BECAME HYPER-STIMULATED AND THE FETAL HEART RATE DECREASED. THE FETAL HEART RATE WAS IN THE 140¿ BEFORE THE REPORTED FREE FLOW. DURING THE REPORTED FREE FLOW, THE FETAL HEART RATE WAS BETWEEN 90-110. AT 0652 TERBUTALINE (DOSE UNKNOWN) WAS ADMINISTERED. AFTER THE ADMINISTRATION OF TERBUTALINE, THE FETAL HEART RATE GRADUALLY INCREASED OVER 4 MINUTE TIME PERIOD FROM 120 TO 160. AFTER THE INCIDENT, ANOTHER PUMP WAS USED TO CONTINUE THE PITOCIN INFUSION. REPORTEDLY, NORMAL LABOR CONTINUED, AND MOTHER AND BABY HAVE BEEN RELEASED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention