BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 7439940 · Received April 18, 2018

    Report

    Report Number
    8010762-2018-00138
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Report Date
    July 31, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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). THE DEVICE WAS INVESTIGATED BY A MAQUET SERVICE TECHNICIAN: THE CONTROL PCBA KIT(RFC) WAS EXCHANGED. THE DEVICE WAS CHECKED AND WAS CHECKED SAFE TO OPERATE. THE DEFECTIVE CONTROL BOARD WILL BE INVESTIGATED FOR FURTHER ACTIONS AT (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 (B)(4). RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. IMPORTER- MAQUET MEDICAL SYSTEMS USA (B)(4). CONTACT PERSON- (B)(6).

    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 (B)(4). CONTACT PERSON: (B)(6). THE DEFECTIVE CONTROL BOARD WAS INVESTIGATED AT LIFE CYCLE ENGINEERING IN GERMANY: THE SCHMITT TRIGGER ON PIN 13 OF IC13 WAS DEFECTIVE. AS A RESULT, THE SIGNALS ON THE SS_SPEED_M LINE CAN NO LONGER BE EVALUATED AND THE SAFETY SYSTEM HAS NO INFORMATION ABOUT THE SPEED OF THE DRIVE. FOR THIS REASON THE ERROR HEAD IS DISPLAYED AT A SPEED OF 1000RPM AND THE DRIVE STOPPED. THIS ERROR IS MOST LIKELY DUE TO THE LUGGING IN OR UNPLUGGING OF THE PUMP HEAD WHILE THE CONSOLE IS SWITCHED ON. THIS FAILURE IS MOST LIKELY DUE TO HOT PLUGGING THE ROTAFLOW DRIVE HEAD. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AFTER NEW INFORMATION HAS BEEN RECEIVED. 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). BEFORE USE/PROCEDURE A HEAD ERROR WAS SHOWN ON THE DISPLAY.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282030 ROTAFLOW CENTRIFUGAL PUMP SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG ROTAFLOW CONSOLE

    Patients

    Seq Age Sex Outcome Treatment
    1