BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS2 MYOCARDIAL PROTECTION SYSTEM CONSOLE

    MDR report key: 5667911 · Received May 19, 2016

    Report

    Report Number
    1649914-2016-00022
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Date of Event
    April 21, 2016
    Report Date
    May 13, 2016
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    UDI-DI
    20634624521265
    PMA / PMN Number
    K041979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED "PUMP INITIALIZE" ERROR WAS DUPLICATED. THE MECHANISM WAS DISASSEMBLED AND CHECKED FOR DEFECTS. THE OUTLET CAM (UPPER) VALVE BEARING HAD COME APART CAUSING THE VALVE TO IMPROPERLY OPERATE. THE BEARING WAS REPLACED AND THE MECHANISM WAS REASSEMBLED. THE CONSOLE PASSED ALL PERFORMANCE AND FUNCTIONAL TESTING AND WAS RELEASED FOR USE.

    Additional Manufacturer Narrative · 1

    QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS CONSOLE DURING USE. HE REPORTED THAT THE CONSOLE DISPLAYED A "LOW INLET PRESSURE" ALARM AND "PUMP INITIALIZING RESUME FLOW" ALARM DURING THE DELIVERY OF THE INITIAL ARREST AGENT DOSE WHILE THE PATIENT WAS ON BYPASS. THE REPORT STATED THAT ATTEMPTS TO REBOOT THE CONSOLE WERE UNSUCCESSFUL. THE PERFUSIONIST REPORTED CHANGING OUT THE CONSOLE FOR ANOTHER ONE AND RESUMING THE PROCEDURE WITH NO COMPLICATIONS TO THE PATIENT. THE CONSOLE WILL RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323063 MPS2 MYOCARDIAL PROTECTION SYSTEM CONSOLE CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5201260 20634624521265

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention