BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAPID RESPONSE UNIVERSAL PACK

    MDR report key: 2535984 · Received April 12, 2012

    Report

    Report Number
    2535984
    Event Type
    Death
    Date Received
    April 12, 2012
    Date of Event
    March 24, 2012
    Report Date
    April 9, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR US SSU, LLC
    Product Code
    DWE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT SUFFERED CARDIAC ARREST AT HOME AND WAS TRANSFERRED TO OUR FACILITY ON (B)(6) 2012. PATIENT REQUIRED ECMO SUPPORT ON (B)(6) 2012. PATIENT REMAINED ON ECMO W/O INCIDENT UNTIL (B)(6) 2012. AT APPROXIMATELY 17:30 ON (B)(6) 2012, THERE WAS CONCERN THAT THE ECMO CIRCUIT HAD CLOTTED DUE TO EVIDENCE OF LOW-FLOW. THE CIRCUIT WAS CHANGED WITHIN 60 SECONDS BUT THE PATIENT BECAME UNRESPONSIVE AND A CT SCAN DEMONSTRATED AN ANOXIC BRAIN INJURY. THE FAMILY ELECTED TO WITHDRAW CARE AND THE PATIENT EXPIRED ON (B)(6) 2012 AT APPROXIMATELY 1700.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID RESPONSE UNIVERSAL PACK ECMO CIRCUIT DWE MAQUET CARDIOVASCULAR US SSU, LLC 13286 701054874

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Death