BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2070442 · Received April 27, 2011

    Report

    Report Number
    6000001-2011-03210
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    February 15, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION ON 04/29/2011. AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THE RESULTS WERE SATISFACTORY; ALL COMPONENTS WERE PRESENT, IN THE RIGHT POSITION, AND COMPLETE. THE SAMPLE WAS THEN SUBMITTED FOR UNDERWATER PRESSURE TESTING AND DELIVERY TESTING WITH NO ABNORMALITIES OBSERVED. THE REPORTED CONDITION WAS NOT CONFIRMED AND NO ROOT CAUSE WAS IDENTIFIED. 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) AN UNKNOWN AMOUNT OF INTERLINK SYSTEM CONTINU-FLO BLOOD/SOLUTION SETS THAT ARE CONTINUALLY HAVING AIR IN LINE ISSUES. ACCORDING TO THE REPORT, THE FACILITY IS HAVING TO CHANGE THE LINE UP TO SIX TIMES OVER A 24 HOUR PERIOD. THE CONDITIONS OCCURRED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT, 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, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - SINGAPORE SR10H24019

    Patients

    Seq Age Sex Outcome Treatment
    1