BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 2051018 · Received April 12, 2011

    Report

    Report Number
    6000001-2011-02786
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 30, 2011
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION PER THE CUSTOMER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLO-GARD INFUSION PUMP WHICH OVERDELIVERED DURING PATIENT USE IN THE EMERGENCY ROOM. THE DEVICE HAD BEEN PROGRAMMED TO DELIVER SALINE TO THE PATIENT AT A RATE OF 35 MILLILITERS PER HOUR. AFTER THE INFUSION WAS STARTED THE NURSE AND PARAMEDIC IN THE PATIENT'S ROOM NOTICED THAT THE DEVICE SOUNDED AS THOUGH IT HAD CHANGED TO DELIVERING AT A HIGHER RATE. OBSERVATION OF THE DEVICE DETERMINED THAT IT WAS DELIVERING AT A HIGHER RATE THAN PROGRAMMED. THE INFUSION WAS STOPPED AND THE DEVICE WAS REPROGRAMMED TO THE ORIGINAL SETTINGS. THE NURSE AND PARAMEDIC ATTEMPTED TO RUN THE INFUSION, HOWEVER THE DEVICE AGAIN BEGAN TO DELIVER AT A HIGHER RATE THAN PROGRAMMED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP PUMP, INFUSION FRN UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR