BEUDAMED
    FDA Adverse Event Death Summary report: N

    MPS 2 CONSOLE

    MDR report key: 7981760 · Received October 18, 2018

    Report

    Report Number
    1649914-2018-00086
    Event Type
    Death
    Date Received
    October 18, 2018
    Date of Event
    September 21, 2018
    Report Date
    October 18, 2018
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K041979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSOLE WAS RECEIVED AND EVALUATED BY QUEST AND THE "TRICKLE" DELIVERY REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. DURING REVIEW OF THE LOG DATA, NO SIGNIFICANT ERROR MESSAGES WERE SEEN. HOWEVER, A NUMBER OF "PRESSURE OVERLIMIT" MESSAGES WERE SEEN. WHEN THIS MESSAGE IS DISPLAYED, TYPICALLY THE FLOW TO THE TABLE IS REDUCED BY THE USER TO PREVENT HARM TO THE PATIENT. A REDUCTION IN FLOW MAY THEREFORE HAVE BEEN THE REASON FOR THE "TRICKLE". THE "PRESSURE OVERLIMIT" MESSAGE WAS NOT OBSERVED CONSISTENTLY THROUGHOUT THE CASE. AS PART OF THE INVESTIGATION PROCESS, THE CONSOLE WAS DISASSEMBLED AND INSPECTED AND NO DEFECTS WERE FOUND. THE CONSOLE WAS RE-ASSEMBLED AND TESTED AND IT PASSED ALL FUNCTIONAL VERIFICATION TESTING. THE RESULTS FROM OUR INVESTIGATION INDICATES THAT THE CONSOLE DID NOT LIKELY CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT. QUEST MEDICAL HAS NO INFORMATION ON THE PATIENT'S MEDICAL CONDITION OR OTHER MEDICAL/SURGICAL FACTORS WHICH MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    A CALL WAS RECEIVED FROM THE CHIEF OF PERFUSION AT (B)(6) WHO NOTIFIED QUEST ABOUT THE INCIDENT. HIS REPORT STATES THAT DURING A CASE, THE MPS CONSOLE WAS DELIVERING A "TRICKLE" THROUGHOUT THE ENTIRE CASE. THE CONSOLE WAS REBOOTED, HOWEVER THE ISSUE WAS STILL PRESENT. THE CONSOLE DID NOT PRODUCE ANY ALARM MESSAGES AND THE FLOWRATES AND PRESSURES APPEARED TO BE NORMAL. HE FURTHER STATED THAT THE PATIENT DID NOT SURVIVE ONCE CONCLUDING THE CASE AND PLACING ON ECMO. HE ALSO STATED THAT THE CASE LASTED APPROXIMATELY 15 HOURS AND THERE WERE OTHER ISSUES NOT RELATED TO THE MPS CONSOLE. ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY STATES THAT THE ISSUE OCCURED WHILE DELIVERING ANTEGRADE CARDIOPLEGIA (K+ AND ADDITIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818374 MPS 2 CONSOLE CPBP HEAT EXHANGER DTR QUEST MEDICAL, INC. 5201260 3125

    Patients

    Seq Age Sex Outcome Treatment
    1 Death