BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3021981 · Received March 26, 2013

    Report

    Report Number
    1416980-2013-07328
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE TUBE WAS DISCONNECTED FROM THE CHAMBER. FURTHER VISUAL INSPECTION OF THE TUBE END REVEALED THAT THE TUBE WAS LOW INSERTED INTO THE CHAMBER. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE TUBE OF A SOLUTION ADMINISTRATION SET WAS DISCONNECTED FROM THE CHAMBER. THE REPORTED CONDITION OCCURRED DURING INFUSION. A PATIENT WAS INVOLVED, BUT THERE IS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION NEEDED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123023 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 12H31V644

    Patients

    Seq Age Sex Outcome Treatment
    1