BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 6185302 · Received December 19, 2016

    Report

    Report Number
    8010762-2016-00727
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 22, 2016
    Report Date
    May 30, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K123510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE TECHNICIAN HAS BEEN SENT FOR MAINTENANCE. FOLLOWING WORKS HAS BEEN DONE DURING SERVICE: THE TECHNICIAN DETECTED AN ERROR HEAD AND NO FLOW BUT RPM ABOVE 1000 TRIGGERS. THE FIELD SERVICE TECHNICIAN HAS REPLACED THE RFC CONTROL BOARD KIT AND THE FLOW MEASURE BOARD FOR RFC. MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE DEFECTIVE RFC CONTROL BOARD KIT IS NOT AVAILABLE FOR FURTHER INVESTIGATION. THUS THE FAILURE COULD BE CONFIRMED. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME. SINCE THE REPORTED FAILURE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY NO CORRECTIVE ACTION IS NEEDED. IN ADDITION AT THIS TIME IT CANNOT BE CONCLUDED THAT THIS IS A SYSTEMIC.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS STARED THAT THE DEVICE HAD AN ERROR HEAD WHEN THEY TRIGGERS ABOVE 1000 RPM. THE ERROR HAPPENED DURING MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835673 ROTAFLOW CENTRIFUGAL PUMP SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG ROTA FLOW CONSOLE

    Patients

    Seq Age Sex Outcome Treatment
    1