BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 7486963 · Received May 4, 2018

    Report

    Report Number
    8010762-2018-00159
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Date of Event
    April 11, 2018
    Report Date
    February 22, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4).

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS,USA(IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31, 76437 RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. IMPORTER- MAQUET MEDICAL SYSTEMS USA 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON- (B)(4). THE ROTAFLOW CONSOLE WAS INVESTIGATED WITH THE MAQUET - SERVICE ORDER NUMBER (B)(4) BY A GETINGE SERVICE TECHNICIAN ON THE 2018-04-26: A FAILURE COULD BE CONFIRMED THEREFORE THE CONTROL BOARD KIT (PCBA) WAS EXCHANGED. NO EXCHANGED PART DOES EXIST THEREFORE NO PROBABLE ROOT CAUSE IS POSSIBLE. NO SERVICE PROTOCOL DOES EXIST THEREFORE IT CANNOT BE GUARANTEED THAT THE MACHINE IS FULLY FUNCTIONAL AGAIN. 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.

    Description of Event or Problem · 0

    (B)(4). DURING MAINTENANCE/ SERVICE A "HEAD ERROR" WAS SHOWN WHEN STARTING. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    INTERNAL REFERENCE#:(B)(4). ONE SUPPORT#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331649 ROTAFLOW CENTRIFUGAL PUMP SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG ROTAFLOW CONSOLE

    Patients

    Seq Age Sex Outcome Treatment
    1