BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUEST MYOCARDIAL PROTECTION SYSTEM

    MDR report key: 2428580 · Received January 20, 2012

    Report

    Report Number
    1649914-2012-00001
    Event Type
    Injury
    Date Received
    January 20, 2012
    Date of Event
    December 29, 2011
    Report Date
    December 29, 2011
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). QUEST MEDICAL, INC HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT AT THE BEGINNING OF THE CARDIOPLEGIA PROCEDURE DURING ADMINISTRATION OF THE INDUCTION DOSE, HE OBSERVED A WATER LEAK FROM THE MPS CONSOLE. HE REPORTED THE WATER APPEARED TO BE COMING FROM THE HEAT EXCHANGER AND HE SUBSEQUENTLY HEARD A GRINDING NOISE. THE PERFUSIONIST REPORTED THE CONSOLE THEN DISPLAYED AN ERROR CODE AND USE OF THE CONSOLE WAS CEASED. THE CROSS CLAMP WAS REMOVED AND THE PT'S HEART FIBULATED FOR APPROX 10-15 MINUTES WHILE THE CONSOLE WAS REPLACED BY ANOTHER UNIT. IT WAS REPORTED THAT THE INDUCTION DOSE WAS SUCCESSFULLY COMPLETED AND THE PROCEDURE COMPLETED WITH NO PT COMPLICATIONS NOTED. THE CONSOLE WAS RETURNED TO THE MFR FOR ANALYSIS. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUEST MYOCARDIAL PROTECTION SYSTEM CARDIPLEGIA DELIVERY SYTEM DTR QUEST MEDICAL, INC. 5001000

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention