BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 5637226 · Received May 6, 2016

    Report

    Report Number
    8010762-2016-00322
    Event Type
    Malfunction
    Date Received
    May 6, 2016
    Date of Event
    April 11, 2016
    Report Date
    April 13, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 MAQUET (B)(4). A MAQUET FIELD SERVICE TECHNICIAN EVALUATED THE RFC ((B)(4)). IT COULD BE CONFIRMED THAT THE FLOW CONTROL BOARD AS WELL AS THE SYSTEM CONTROL BOARD WERE DAMAGED ON THIS RFC. IT CANNOT FINALLY BE DETERMINED WHAT CAUSED THE DAMAGES ON THE BOARDS. MOST LIKELY THOSE DAMAGES WERE CAUSED BY "HOTPLUG" OF THE RFD. "HOTPLUG" DESCRIBES THE DISCONNECTION OF THE DRIVE, WHILE THE CONSOLE IS STILL TURNED ON. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU): SWITCH OFF THE ROTAFLOW CONSOLE ON/OFF SWITCH BEFORE CONNECTING THE ROTAFLOW DRIVE TO OR DISCONNECTING IT FROM THE ROTAFLOW CONSOLE. OTHERWISE THE ROTAFLOW CONSOLE OR DRIVE MAY BE DAMAGED. THE CAUSE FOR THE INITIAL DISPLAY OF THE ERROR MESSAGE REMAINS UNCLEAR. IT IS POSSIBLE THAT A RESTRICTION IN BLOOD FLOW DUE TO THE REPORTED BLOOD CLOTT CAUSED THE ERROR MESSAGE. HOWEVER, SINCE THE INSTRUCTIONS WERE NOT FOLLOWED WHILE REPLACING THE DEVICE AND HEREBY THE DEVICE WAS FURTHER DAMAGED, IT CAN NO LONGER BE DETERMINED WHAT CAUSED THE DESCRIBED EVENT. THE DAMAGED BOARDS WERE REPLACED AND THE SYSTEM WAS SUCCESSFULLY TESTED TO MANUFACTURER SPECIFICATION. THE ERROR MESSAGE THAT OCCURRED ON THE SECOND RFC ((B)(4)) MENTIONED WILL BE ADDRESSED IN A SEPARATE COMPLAINT ((B)(4)).

    Description of Event or Problem · 1

    IT WAS DESCRIBED THAT DURING PATIENT TREATMENT BLOOD CLOTTING WAS NOTICED WITHIN THE DISPOSABLE SYSTEM, CAUSING A RESTRICTION IN BLOOD FLOW. THIS RESULTED IN THE DISPLAY OF THE ERROR MESSAGE "HEAD ERROR" ON THE ROTAFLOW CONSOLE (RFC). IT WAS DECIDED TO REPLACE THE RFC ((B)(4)), STILL USING THE SAME ROTAFLOW DRIVE (RFD) UNIT ((B)(4)). ON THE SECOND RFC ((B)(4)) USED THE "HEAD ERROR" ERROR MESSAGE STILL REMAINED CAUSING THE DECISION TO CHANGE BACK TO THE FIRST RFC ((B)(4)). NO CONSEQUENCES TO THE PATIENT WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293491 ROTAFLOW CENTRIFUGAL PUMP SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG ROTAFLOW CONSOLE

    Patients

    Seq Age Sex Outcome Treatment
    1