BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 5452434 · Received February 22, 2016

    Report

    Report Number
    8010762-2016-00104
    Event Type
    Malfunction
    Date Received
    February 22, 2016
    Date of Event
    December 16, 2016
    Report Date
    February 4, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FEB. 22, 2016 03:50 PM (GMT-5:00) ADDED BY (B)(6): (B)(4). THE DEVICE IN QUESTION IS OWNED BY MAQUET (B)(4). AND IS PROVIDED TO HOSPITALS AS A LOANER UNIT. THE REPORTED FAILURE WAS NOT NOTICED IN THE HOSPITAL PRIOR TO THE MAINTENANCE. THE MANUFACTURER HAS REQUESTED THE DEVICE FOR FURTHER EVALUATION AND REPAIR.

    Description of Event or Problem · 1

    FEB. 22, 2016 03:28 PM (GMT-5:00) ADDED BY (B)(6): IT WAS REPORTED THAT A "READ ERROR" OCCURRED DURING MAINTENANCE. THE ERROR MESSAGE "READ ERROR" IS UNKNOWN TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 4TH 2016: THE ACTUAL ERROR MESSAGE THAT WAS DISPLAYED WAS A "HEAD ERROR." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109734 ROTAFLOW CENTRIFUGAL PUMP SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG ROTAFLOW DRIVE

    Patients

    Seq Age Sex Outcome Treatment
    1