BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 119881 · Received September 12, 1997

    Report

    Report Number
    6000001-1997-00993
    Event Type
    Malfunction
    Date Received
    September 12, 1997
    Date of Event
    August 1, 1997
    Report Date
    August 13, 1997
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE INFUSION PUMP WAS FURTHER EVALUATED BY BAXTER HEALTHCARE. THE DEVICE UTILIZES A 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 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

    THE INFUSION PUMP WAS REC'D AT A BAXTER AUTHORIZED SVC FACILITY WITH A NOTE STATING "AIR SENSOR BROKEN". NO ADD'L INFO WAS REC'D FROM THE HOSP. THE BIOMEDICAL ENGINEERING AND RISK MANAGMENT DEPTS AT THE HOSP WERE NOT AWARE OF ANY ISSUE WITH THE INFUSION PUMP OR ANY INCIDENT WITH THE AIR SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. 6201 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN