BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS MYOCARDIAL PROTECTION SYSTEM

    MDR report key: 1873491 · Received September 22, 2010

    Report

    Report Number
    1649914-2010-00019
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 22, 2010
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): METHOD: PERFORMANCE TESTS OF ALL SPECIFICATIONS PERFORMED. RESULTS: ELECTRICAL PROBLEM.

    Description of Event or Problem · 1

    MPS CONSOLE WAS BEING USED IN A SURGICAL PROCEDURE WHEN IT DISPLAYED AN "EXCESSIVE INLET PRESSURE" ALARM, ERROR CODE 219. THE CUSTOMER ATTEMPTED TO RESOLVE THE ISSUE BY POWERING THE UNIT OFF AND ON AGAIN AND THEN PUSHING THE RESUME CASE BUTTON. THE ALARM CONTINUED TO REPEAT ITSELF. THE CUSTOMER THEN SWITCHED OUT THIS CONSOLE WITH ANOTHER MPS CONSOLE KEPT AS A BACK-UP. THE CROSS CLAMP WAS REMOVED WHILE THE CONSOLE WAS CHANGED OUT. THE BACK-UP CONSOLE WORKED AND THE CASE WAS COMPLETED USING THE BACK-UP CONSOLE. THE CUSTOMER STATED THAT THERE WERE NO PT COMPLICATIONS; HOWEVER, MEDICAL OR SURGICAL INTERVENTION WAS NECESSARY TO PRECLUDE PERMANENT IMPAIRMENT OR DAMAGE. THERE WAS NO INJURY THAT WAS ASSOCIATED WITH THIS EVENT. THE REMOVAL OF THE CROSS CLAMP SIMPLY EXTENDED THE TOTAL SURGERY TIME BY SEVERAL MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPS MYOCARDIAL PROTECTION SYSTEM HEAT-EXCHANGER, CARDIOPULMONARY BYPASS DTR QUEST MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention