BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON ELITE BI-CAVAL DUAL

    MDR report key: 3242632 · Received July 19, 2013

    Report

    Report Number
    3008355164-2013-00174
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 22, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K081820
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE (B)(4). PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS PLACED ON VENO VENOUS EXTRACORPEAL LIFE SUPPORT ON (B)(6) 2013, THE CATHETER MIGRATED OUT OF THE INFERIOR VENA CAVA AND CREATED A PERICARDIAL EFFUSION ON (B)(6) 2013. THE CATHETER WAS REMOVED. PATIENT HAS RECOVERED AND IS DOING WELL. REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338861 AVALON ELITE BI-CAVAL DUAL CATHETER DWF MAQUET CARDIOPULMONARY AG AVALON ELITE 16F NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Required Intervention