BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 6092852 · Received November 10, 2016

    Report

    Report Number
    8010762-2016-00668
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Report Date
    April 3, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT TO MAQUET CARDIOPULMONARY(MCP) FOR INSPECTION: THE FAILURE COULD BE CONFIRMED. AFTER THAT THE DEVICE WAS INVESTIGATED BY (B)(4): THEY FOUND OUT THAT THE DEVICE HAS A BEARING DAMAGE OF THE ENGINE. THIS LEADS TO THE FAILURE OF THE SPEED CONTROL OF THE MOTOR. ADDITIONAL DEFICIENCIES: ELECTRONIC BOARDS MC1 AND MC2 HAVE TO BE REPLACED. MASTHOLDER WITH THE COMPONENTS ARE STRONGLY OXIDIZED AND RUSTED. CONNECTION CABLE OF ROTAFLOW IS TOO SHORT. THE CUSTOMER WANTS THE DEVICE UNREPAIRED BACK BECAUSE OF THE HIGH REPAIR COST. 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 AS A SYSTEMIC ERROR. NO CORRECTIVE ACTION IS NEEDED. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    (B)(4). IT WAS STARTED THAT AN ERROR HEAD ON ROTAFLOW OCCURED WHEN RPM INCREASES. NO KNOWN CONSEQUENCES TO PATIENT.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744044 ROTAFLOW CENTRIFUGAL PUMP SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG ROTAFLOW

    Patients

    Seq Age Sex Outcome Treatment
    1