BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 6017208 · Received October 11, 2016

    Report

    Report Number
    8010762-2016-00618
    Event Type
    Death
    Date Received
    October 11, 2016
    Date of Event
    September 10, 2016
    Report Date
    September 21, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    "PERFUSIONIST FOUND FLOW TO BE LOW EVEN THOUGH RPM'S STAYED CONSTANT. SUSPECTED CLOTTING AS POSSIBLE CAUSE. MOVED CIRCUIT TO HAND CRANK AND ESTABLISHED BETTER FLOW. PERFUSIONIST WAS MOVING BACK TO PUMP WHEN PATIENT EXPIRED. CUSTOMER DOES NOT FEEL ROTAFLOW CONTRIBUTED TO PATIENTS DEATH. CUSTOMER NOT REPORTING TO AUTHORITIES. NO INCIDENT REPORTED. PATIENT WAS VERY SICK WITH MULTIPLE ISSUES. CUSTOMER REQUESTED A ROUTINE CHECK OUT AS A PRECAUTION. TESTED UNIT WITH CIRCUIT. PERFORMED FUNCTIONAL AND SAFETY TESTS. UNIT FUNCTIONS ACCORDING TO FACTORY SPECIFICATIONS. RETURNED TO SERVICE AND CLEARED FOR CLINICAL USE." INTERNAL REFERENCE: #122701 CUSTOMER REFERENCE: CP-CPL-2016-000595

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667912 ROTAFLOW CENTRIFUGAL PUMP SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG ROTAFLOW

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death