BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6301 DUAL CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 114487 · Received August 19, 1997

    Report

    Report Number
    6000001-1997-00922
    Event Type
    Malfunction
    Date Received
    August 19, 1997
    Date of Event
    July 1, 1997
    Report Date
    July 21, 1997
    Manufacturer
    BAXTER HEALTHCARE PTE LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION INFO: THE INFUSION PUMP WAS EVALUATED BY BAXTER HEALTHCARE. THE DEVICE UTILIZES AN ULTRASONIC SENSOR, WHERE AIR WOULD TRANSMIT THE SIGNAL POORLY AND STIMULATE AN AIR ALARM. WHEN AN AIR FILLED INTRA VENOUS TUBING WAS LOADED INTO THE PUMP THE TRANSMITTED ULTRASONIC SIGNAL DID NOT DROP BELOW THE THRESHOLD TO INITIATE AN AIR ALARM. CO'S RECORDS INDICATE THAT THE AIR SENSOR WAS SUCCESSFULLY TESTED IN MAY OF 1995. HOWEVER, FURTHER INSPECTION SHOWED NO DIRECT CAUSE FOR THE CHANGE IN THE AIR SENSOR VALUES THAT WERE OBSERVED. THE AIR SENSING SYSTEM FOR THE PUMP WAS RECALIBRATED BEFORE THE PUMP WAS RETURNED TO THE HOSP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE TESTING BY THE HOSPITAL BIOMEDICAL ENGINEERING DEPT, CHANNEL ONE OF THE PUMP DID NOT DETECT A 110 MICROLITER SIZE AIR GAP. THERE WAS NO CLINICAL INCIDENT.

    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. 6301 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA