BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUIPO MINIPRIME 8MM C/SET AUTOMATIZADO PARA MAQUINA TINA

    MDR report key: 1913140 · Received December 2, 2010

    Report

    Report Number
    1423500-2010-06460
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE ACTUAL SAMPLE WAS RETURNED AND EVALUATED. THE REPORTED ISSUE WAS NOT CONFIRMED. NO DEFECT WAS EVIDENCED DURING VISUAL AND LEAK TESTS OF THE SAMPLE.

    Description of Event or Problem · 1

    THIS REPORT IS THE RESULT OF A CUSTOMER CONTACTING BAXTER. THE CUSTOMER REPORTED THAT THE CHAMBER WAS FILLED WITH BUBBLES. PATIENT INJURY AND MEDICAL INTERVENTION WERE NOT REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUIPO MINIPRIME 8MM C/SET AUTOMATIZADO PARA MAQUINA TINA SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK BAXTER HEALTHCARE - CALI SX10HF6

    Patients

    Seq Age Sex Outcome Treatment
    1