BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIN SET. FOR LBL. BLD. DERIVW LL

    MDR report key: 1940965 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06316
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    November 25, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE CONFIRMED THE TUBE HAD A CUT. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE ROOT CAUSE OF THIS CONDITION IS ATTRIBUTED TO THE SET CHANGING ORIENTATION DURING MACHINE INDEXING IN THE PACKAGING PROCESS. THIS COMPLAINT SHALL BE COMMUNICATED TO THE MANUFACTURING AREA AND QUALITY ASSURANCE RESPONSIBLE AT THE PLANT FOR THE PRODUCTION OF THE CODE MENTIONED IN THIS COMPLAINT TO ENSURE AWARENESS OF THIS COMPLAINT AND STRICT ADHERENCE TO RELEVANT REQUIREMENTS. BAXTER SHALL KEEP MONITORING THESE EVENTS DURING QUALITY REVIEWS. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A BLOOD DRIP CHAMBER SET WITH 200MICRON FILTER AND BALL VALVE THAT HAD A LARGE HOLE IN THE LINE. THE CONDITION WAS IDENTIFIED DURING PRIMING AND THERE WAS NO PATIENT INVOLVEMENT. 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 ADMIN SET. FOR LBL. BLD. DERIVW LL SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - MALTA 10H19V466

    Patients

    Seq Age Sex Outcome Treatment
    1