BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2120173 · Received June 10, 2011

    Report

    Report Number
    6000001-2011-07441
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - SHERBROOKE
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. HOWEVER, A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH CAPA RSP-CAPA-(B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN 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) REGARDING THE CLEARLINK Y-TYPE BLOOD SOLUTION SET THE TUBING UNDER THE DRIP CHAMBER WENT OFF DURING A BLOOD PERFUSIONS. THE PROBLEM WAS NOTED DURING PATIENT USE, TOWARDS THE BEGINNING AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.THIS IS REPORT 2 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - SHERBROOKE ST11B249

    Patients

    Seq Age Sex Outcome Treatment
    1