BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2091859 · Received May 17, 2011

    Report

    Report Number
    6000001-2011-04155
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED TO THE SET AND THE RESULTS WERE SATISFACTORY; ALL COMPONENTS WERE PRESENT, IN THE RIGHT POSITION AND COMPLETE. THE SAMPLE WAS SUBMITTED FOR AN UNDER WATER PRESSURE TEST WHICH REVEALED THE ROLLER CLAMP WAS DEFECTIVE BECAUSE IT COULD ALLOW A LEAK IN THE ASSEMBLY WITH THE GUIDE TUBE. A PULL TEST (B)(4) WAS APPLIED TO THE COMPONENTS BONDING ASSEMBLY, AND NO SEPARATION OF COMPONENTS WAS OBSERVED. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE OF THIS CONDITION WAS ATTRIBUTED TO A DEFORMATION IN CLAMP CAUSED BY VARIATION IN THE HEIGHT OF THE CAVITY OF THE MOLD. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A BURETROL SOLUTION ADMINISTRATION SET IN WHICH THE ROLLER CLAMP DOES NOT REGULATE. THE CONDITION WAS IDENTIFIED DURING SET UP BEFORE PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - CALI SX11BV2

    Patients

    Seq Age Sex Outcome Treatment
    1