BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOCARDIAL PROTECTION SYSTEM MPS2 CONSOLE

    MDR report key: 6131907 · Received November 29, 2016

    Report

    Report Number
    1649914-2016-00060
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    October 31, 2016
    Report Date
    November 14, 2016
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    UDI-DI
    20634624521265
    PMA / PMN Number
    K041979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE CONSOLE WAS ABLE TO DUPLICATE THE REPORTED ERRORS. AFTER THE CONSOLE WAS DISASSEMBLED THE FSE FOUND A SUBSTANTIAL AMOUNT OF FLUID INTRUSION ON THE SOLENOID DRIVER PCB. THE PARTS WERE REMOVED AND REPLACED, BUT THE SOURCE OF THE FLUID LEAK COULD NOT BE DETERMINED. AFTER REASSEMBLY, THE CONSOLE WAS TESTED AND THE FSE NOTICED A LEAK FROM THE HEAT EXCHANGER LOCKING KNOB. AFTER THE LEAK WAS FIXED, THE ISSUE RETURNED. THE CONSOLE WAS REOPENED AND FLUID WAS FOUND ON THE PCB AGAIN. IT APPEARED TO COME FROM THE BOTTOM OUTLET PORTS FROM THE HEAT EXCHANGER ASSEMBLY. THE CONSOLE WAS RETURNED TO THE MANUFACTURER DUE TO THE NATURE OF THE ISSUE. ONCE THE CONSOLE WAS RECEIVED AT QUEST, THE CONSOLE WAS DISASSEMBLED AND INVESTIGATED. THE FSE NOTICED HAIRLINE CRACKS ON THE HEAT EXCHANGER AT THE LOCATION WHERE THE NYLON FITTINGS ATTACH. THE HEAT EXCHANGER ASSEMBLY WAS CHANGED AND THE CONSOLE WAS REASSEMBLED. CONSOLE 2480 PASSED THE OPERATIONAL VERIFICATION TEST. THE ROOT CAUSE FOR THE CRACKS IS UNKNOWN.

    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 MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS2 CONSOLE DURING USE. HE STATED THAT THE CONSOLE LEAKED WATER DURING THE PROCEDURE, AND AT SOME POINT DISPLAYED MULTIPLE ALARMS LIKE "RETRO VALVE FAIL", "VENT VALVE FAIL", AND "INTERNAL TIMING ERROR." THE PERFUSIONIST REPORTED HE REBOOTED THE CONSOLE THREE TIMES PRIOR TO THE PROCEDURE EVEN STARTING DURING THE DIAGNOSTICS TESTING. THE REPORT STATED THAT LATER IN THE PROCEDURE WHEN IT WAS TIME TO DELIVER WARM CARDIOPLEGIA THE SURGEON DID NOT WANT TO WAIT FOR THE CONSOLE TO HEAT UP AND CHOSE TO TAKE THE CROSS CLAMP OFF INSTEAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE MANUFACTURER FIELD SERVICE ENGINEER WILL TRAVEL TO THE FACILITY TO EVALUATE THE CONSOLE AND REPAIR AS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784670 MYOCARDIAL PROTECTION SYSTEM MPS2 CONSOLE CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5201260 20634624521265

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention