BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET TUBING SET

    MDR report key: 2160949 · Received June 16, 2011

    Report

    Report Number
    8010762-2011-00006
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 15, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K102726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOVASCULAR SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). THE ACTUAL COMPLAINT SAMPLE WAS RETURNED AND VISUALLY INSPECTED. DURING THE PRODUCT EVAL THE REPORTED COMPLAINT OF THE VENOUS AND ARTERIAL LINES BEING SWITCHED WAS CONFIRMED. THE AFFECTED BATCH CONSISTS OF FIFTY TUBING SETS IN TOTAL. SO FAR, THIS IS THE ONLY REPORTED TUBING SET AFFECTED WITHIN THE BATCH. A RECALL OF THIS AFFECTED BATCH HAS BEEN CONDUCTED IN THE AFFECTED COUNTRIES. NO PRODUCT FROM BATCH 70060884 WAS DISTRIBUTED IN THE UNITED STATES. ITEMS MARKED NI ARE UNK TO US AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE VENOUS LINE AND THE ARTERIAL LINE CONNECTED TO THE OXYGENATOR WERE INTERCHANGED. THE VENOUS LINE WAS CONNECTED TO THE ARTERIAL PORT AND THE ARTERIAL LINE WAS CONNECTED TO THE VENOUS PORT OF THE OXYGENATOR. THE ERROR WAS FOUND DURING THE PRIMING PROCEDURE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET TUBING SET TUBING SET FOR CARDIAC/PULM SUPPORT DTQ MAQUET CARDIOPULMONARY AG BE-HLS 7050 70060884

    Patients

    Seq Age Sex Outcome Treatment
    1 NI