BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3082686 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10660
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ORIGINAL REPORT OF A FILTER WITHOUT A VENT SHOULD HAVE STATED A "DRIP CHAMBER" WITHOUT A VENT. IT WAS CONFIRMED THAT THE DRIP CHAMBER, OF THE ACTUAL SAMPLE, WAS MISSING AN AIR VENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. ONE ACTUAL SAMPLE AND THREE COMPANION SAMPLES WERE RECEIVED FOR EVALUATION. ALL SAMPLES WERE VISUALLY INSPECTED. THE THREE COMPANION SAMPLES WERE OBSERVED TO HAVE THE CORRECT FILTER (WITH AN AIR-VENT), HOWEVER THE ACTUAL SAMPLE WAS OBSERVED TO HAVE A FILTER WITHOUT AN AIR-VENT. THE VISUAL INSPECTION CONFIRMED THE REPORTED CONDITION. THE CAUSE WAS DETERMINED TO BE AN ISSUE WITH THE MANUFACTURING PROCESS. AS A RESULT, RETRAINING WAS PERFORMED WITH THE OPERATORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FILTER OF A FLOGARD IV SOLUTION ADMINISTRATION SET DID NOT HAVE A VENT. THIS MALFUNCTION WAS IDENTIFIED BEFORE USE, THEREFORE, THERE WAS NOT PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184452 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 13B28V471

    Patients

    Seq Age Sex Outcome Treatment
    1