BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3103091 · Received May 9, 2013

    Report

    Report Number
    1416980-2013-11845
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 18, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED, HOWEVER NO VISUAL DEFECT COULD BE FOUND. A PRESSURE TEST WAS THEN PERFORMED AND A LEAK WAS FOUND. THEREFORE THE CUSTOMER REPORTED LEAK WAS CONFIRMED. THE CAUSE WAS IDENTIFIED AS A MANUFACTURING PROCESS ISSUE. A CAPA HAS BEEN OPENED IN ORDER TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT OCCURRENCE DATE IS UNKNOWN. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A Y-TYPE BLOOD SOLUTION SET'S TUBING LEAKED JUST UNDER THE SPIKE BEFORE THE ROLLER CLAMP. THE TUBING WAS REPORTED TO BE "COMING APART FROM THE SPIKE." THIS WAS REPORTED TO HAVE OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202869 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE R12G28051

    Patients

    Seq Age Sex Outcome Treatment
    1