BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET

    MDR report key: 1822489 · Received July 20, 2010

    Report

    Report Number
    8010762-2010-13510
    Event Type
    Other
    Date Received
    July 20, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 24, 2010
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K053025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, THE VERIFICATION OF THE LOT SPECIFIC PRODUCTION DOCUMENTATION SHOWS THAT THE REPORTED NONCONFORMITY IS RELATED TO A WRONG TECHNICAL DRAWING: THE POSITION OF THE COLOR TAPES ON THE AFFECTED LINE WAS DEFINED INCORRECTLY IN THE TECHNICAL DRAWING OF THE TUBING SET. MAQUET CARDIOVASCULAR SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. MAQUET CARDIOVASCULAR IS SUBMITTING AN ADDITIONAL INITIAL REPORT AS THE UF/IMPORTER REPORTER. THE UF/IMPORTER REPORT NUMBER WAS ADDED TO THE FORM AND THE MFR REPORT NUMBER WAS REMOVED. MFR. REPORT #: 8010762-2010-13510. (B)(4). UF/IMPORTER REPORT#: 30083551643-2010-13510. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS CONNECTED TO THE EXTRACORPOREAL CIRCULATION (TUBING SYSTEM BEQ-TOP 14801). AFTER INITIATION OF THE BYPASS IT WAS NOTICED THAT THE VENOUS DRAINAGE WAS POOR. THE SYSTEM WAS CHECKED IMMEDIATELY FOR ANY ERROR. AFTER CHECKING THE LINES AND TRACKING EVERYTHING IT WAS NOTICED THAT THE COLOR TAPES ON THE ARTERIAL AND THE VENOUS LINE WERE PLACED INCORRECTLY. DUE TO THIS THE CONNECTION OF THE ARTERIAL AND THE VENOUS LINE WAS INTERCHANGED. THE AFFECTED LINES WERE SWITCHED TO THE PROPER POSITION AND THE PROCEDURE WAS BEGUN SUCCESSFULLY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET TUBING SET FOR CARDIAC/PULM SUPPORT DWE MAQUET CARDIOPULMONARY AG BEQ-TOP 14801 70046759

    Patients

    Seq Age Sex Outcome Treatment
    1 NI