BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD

    MDR report key: 3053500 · Received April 11, 2013

    Report

    Report Number
    1416980-2013-09053
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PROBLEM OF OCCLUSION WAS CONFIRMED DURING THE SAMPLE EVALUATION. THE CAUSE OF THE REPORTED PROBLEM WAS IDENTIFIED TO BE A DOWNSTREAM OCCLUSION SENSOR THAT WAS OUT OF CALIBRATION. TO RESOLVE THE REPORTED PROBLEM, THE DOWNSTREAM OCCLUSION SENSOR WAS RECALIBRATED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER THAT A FLO-GARD PUMP DISPLAYED AN OCCLUSION ALARM. THE PROCESS STEP WAS NOT INDICATED. THERE WAS NO PATIENT INVOLVED, NO MEDICAL INJURY OR ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154721 FLO-GARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1