BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON ELITE BI-CAVAL DUAL

    MDR report key: 3422334 · Received September 26, 2013

    Report

    Report Number
    8010762-2013-00048
    Event Type
    Malfunction
    Date Received
    September 26, 2013
    Report Date
    August 28, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K081820
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS ON VENO VENOUS EXTRACORPOREAL LIFE SUPPORT (ECLS) WITH THE ELITE BI-CAVAL CATHETER AND NEEDED TO SWITCH TO VENO ARTERIAL ECLS. A "Y" CONNECTOR WAS PUT ON THE ELITE CATHETER AND A SECOND LINE WAS INSERTED IN THE FEMORAL. THE DEOXYGENATED BLOOD WAS DRAINED FROM THE LEG AND BOTH LUMENS OF THE ELITE CATHETER WERE USED TO REFUSE THE OXYGENATED BLOOD. THE VENOUS (LARGER) LUMEN OF THE ELITE CATHETER CLOTTED OFF AND WAS REPLACED WITH A STANDARD SINGLE LUMEN CATHETER. THE CUSTOMER IS AWARE THIS WAS OFF LABEL USE BUT THOUGHT IT WAS THE BEST COURSE OF ACTION FOR THE PATIENT AT THE TIME. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488601 AVALON ELITE BI-CAVAL DUAL CATHETER DWF MAQUET CARDIOPULMONARY AG 10031 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention