BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 8105956 · Received November 27, 2018

    Report

    Report Number
    8010762-2018-00309
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    October 10, 2018
    Report Date
    December 13, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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). A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AFTER NEW INFORMATION HAS BEEN RECEIVED. THIS COMPLAINT IS A DOUBLE ENTRY AND WILL BE CLOSED. THE COMPLAINT WILL BE HANDLED UNDER COMPLAINT#(B)(4).- MEDWATCH MFG. # 8010762-2018-00295 (B)(4). . THE SSU CANADA WROTE AN EMAIL AND EXPLAINED ON THE(B)(6)2018:" THAT THE DATA IS ERRONEOUS. ONLY THE ONE SUBMITTED THROUGH OUR LOCAL REQUIREMENTS HAS THE CORRECT DATA." 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    (B)(4). DURING PRIMING OF THE DEVICE A "HEAD ERROR" APPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944909 ROTAFLOW CENTRIFUGAL PUMP SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG ROTAFLOW DRIVE

    Patients

    Seq Age Sex Outcome Treatment
    1