BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOCARDIAL PROTECTION SYSTEM MPS-2 CONSOLE

    MDR report key: 6115258 · Received November 18, 2016

    Report

    Report Number
    1649914-2016-00062
    Event Type
    Death
    Date Received
    November 18, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 12, 2016
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    UDI-DI
    20634624521265
    PMA / PMN Number
    K041979
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S FIELD SERVICE ENGINEER TRAVELED TO THE FACILITY TO INVESTIGATE THE CONSOLE. EXAMINATION OF THE CONSOLE FOUND THAT THE RIGHT OUTLET VALVE SCREW HAD BACKED OUT OF THE VALVE SHAFT. THIS CAUSED THE VALVE TO JAM BETWEEN THE BEARING AND THE NYLON SPACER. THE VALVE ASSEMBLY WAS REPLACED AND THE CONSOLE THEN PASSED OPERATIONAL VERIFICATION TESTS. THE HOSPITAL USES A "CONTINUOUS WARM CARDIOPLEGIA DELIVERY" METHOD WHERE THE HEART REMAINS WARM DURING THE PROCEDURE AS OPPOSED TO COLD CARDIOPLEGIA. 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.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED AN ISSUE ENCOUNTERED WITH THE MPS CONSOLE DURING USE AT THE HOSPITAL. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) CONTACTED THE SALES REPRESENTATIVE THE NEXT DAY TO ARRANGE HIS VISIT TO INVESTIGATE/REPAIR THE CONSOLE AT THE FACILITY AND WAS NOTIFIED VERBALLY THAT THE PATIENT HAD NOT SURVIVED THE PROCEDURE. THE FSE WAS TOLD THE CONSOLE MADE A LOUD "POP" SOUND THEN CEASED TO FUNCTION AS THOUGH IT WAS JAMMED. THE CONSOLE WAS REPAIRED ON-SITE. ADDITIONAL INFORMATION OBTAINED VERBALLY FROM THE CHIEF PERFUSIONIST WAS THAT THE PATIENT HAD "ALMOST CRASHED" PRIOR TO THE START OF THE PROCEDURE, AND THE PROCEDURE WAS IN PROCESS APPROXIMATELY 4.5 HOURS WHEN THE ALLEGED ERROR CODE/CONSOLE ISSUE OCCURRED. THE PERFUSIONIST STATED THAT IT TOOK ABOUT 13 MINUTES TO SWAP OUT CONSOLES BECAUSE HOSPITAL STAFF BROUGHT IN AN OLDER MODEL CONSOLE THAT REQUIRED AN ISOLATION TRANSFORMER. THE PERFUSIONIST STATED THE PATIENT HAD DIED DURING THE PROCEDURE BUT DID NOT PROVIDE EXACT TIME OTHER THAN IT WAS AFTER THE CONSOLES WERE SWAPPED. REQUESTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764470 MYOCARDIAL PROTECTION SYSTEM MPS-2 CONSOLE CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5201260 20634624521265

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R