BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1993597 · Received February 16, 2011

    Report

    Report Number
    6000001-2011-01058
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CONDITION OF FALSE AIR-IN-LINE WAS CONFIRMED THROUGH THE ALARM LOG BUT WAS NOT DUPLICATED. THE AIR SENSOR CALIBRATION VALUES WERE WITHIN SPECIFICATION, THEREFORE AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED. ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "AIR IN LINE - FALSE." (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED ONE FLO-GARD PUMP WITH A FALSE AIR-IN-LINE. THE REPORTED CONDITION OCCURRED DURING POWER UP. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. 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 BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1