BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 6185520 · Received December 19, 2016

    Report

    Report Number
    8010762-2016-00728
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Report Date
    August 7, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K123510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOSPITAL BIOMED SERVICED THE EQUIPMENT IT IS NOT SERVICED BY MAQUET. THEREFORE NO SERVICE AVAILABLE. THE ROTAFLOW WAS USED DURING TRANSPORT OF A PATIENT IN AN AMBULANCE. AS THE ROTAFLOW SYSTEM IS NOT A VALID TRANSPORTABLE DEVICE FOR TRANSPORTATION. THEREFORE MAQUET ASSUME NO RESPONSIBILITY FOR FUNCTIONALITY OF THE DEVICE. DUE TO OFF-LABEL USE THE FAILURE COULD NOT BE CONFIRMED. THE PATIENT WAS UNAFFECTED BY THE INCIDENT. 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 ERROR. 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. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AFTER NEW INFORMATION HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INTERNAL REFERENCE: (B)(4). AUTONUMBER: (B)(4).

    Description of Event or Problem · 1

    (B)(4). WHILE TRANSPORTING A PATIENT IN AN AMBULANCE VAN AND AFTER PLUGGING INTO THE VEHICLE POWER SUPPLY, THE ROTAFLOW UNIT WAS UNABLE TO FUNCTION ON BATTERY POWER. A BATTERY ERROR WAS DISPLAYED ON THE CONSOLE EVERY TIME THEY TRIED TO DISCONNECT. THE DEVICE WAS USED IN "OFF LABEL USE" WITHOUT A TRANSPORT HOLDER FOR THE ROTAFLOW IN THE AMBULANCE VAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836155 ROTAFLOW CENTRIFUGAL PUMP SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG ROTAFLOW CONSOLE

    Patients

    Seq Age Sex Outcome Treatment
    1