BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMODYNAMICS

    MDR report key: 6665918 · Received June 24, 2017

    Report

    Report Number
    2183926-2017-00118
    Event Type
    Malfunction
    Date Received
    June 24, 2017
    Date of Event
    May 25, 2017
    Report Date
    May 25, 2017
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    DQK
    PMA / PMN Number
    K082421
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TROUBLESHOOTING WITH HEMO SUPPORT, THE CUSTOMER CHECKED ALL THE CONNECTIONS AND REPLACED THE EXTENDER AND THE USB CONNECTION. THE SCREEN DISPLAYED A LOSS CONNECTION AND THEN WENT BLANK. (B)(4) WAS CREATED AND A REPLACEMENT VIDEO SPLITTER / EXTENDER, FOUR PORT VGA WAS SENT TO THE CUSTOMER ON (B)(6) 2017. THE FAULTY UNIT ((B)(4), PRODUCT #: 16-00024-00) WAS RETURNED TO MERGE HEALTHCARE FOR EVALUATION AND RECEIVED ON 08JUN2017. THE RESULTS OF THE HARDWARE EVALUATION FOUND NO ISSUES. THE REPAIR ENGINEER RAN THE SWITCH FOR TWO DAYS WITHOUT ISSUES, THE UNIT PASSED ALL TESTS. FURTHER FOLLOW UP WITH THE CUSTOMER DETERMINED THAT AFTER THE VIDEO SPLITTER WAS INSTALLED, THE FLICKERING WAS STILL OCCURRING. A 3RD PARTY TECHNICIAN WAS SCHEDULED TO GO TO THE CUSTOMER SITE TO TROUBLESHOOT THE ISSUE. THEREFORE, (B)(4) WERE CREATED. UNDER (B)(4), A REPLACEMENT 75' TRUNK CABLE 1 END TERM OPTION WAS SENT TO THE CUSTOMER ON (B)(6) 2017. THE FAULTY UNIT WAS SCRAPPED ONSITE BY THE CUSTOMER. UNDER (B)(4), A REPLACEMENT COILED TRUNK CABLE KIT WAS SENT TO THE CUSTOMER ON (B)(6) 2017. THE FAULTY UNIT WAS ALSO SCRAPPED ONSITE BY THE CUSTOMER. DURING ONSITE TROUBLESHOOTING WITH THE INSTALLATION TECHNICIAN, BOTH THE CLIENT AND HEMO PC IN THE LAB WERE UPGRADED TO HEMO VERSION (B)(4) PATH1, HOWEVER THE FREEZING PERSISTED. THEREFORE, (B)(4) WAS CREATED AND A REPLACEMENT HEMO PC FRU WAS SENT TO THE CUSTOMER ON (B)(6) 2017. THE FAULTY UNIT ((B)(4), PRODUCT #: 99999-3583) WAS SENT BACK TO MERGE HEALTHCARE FOR EVALUATION AND RECEIVED ON 22JUN2017. THE RESULTS OF THE HARDWARE EVALUATION FOUND NO PROBLEMS. THE UNIT RAN FOR ONE WEEK WITH NO ISSUES. FULL SYSTEM DIAGNOSTICS WAS RAN NUMEROUS TIMES WITH NO ISSUES. THE REPLACEMENT PARTS WERE RECEIVED BY THE CUSTOMER AND INSTALLED. FOLLOW UP WITH THE CUSTOMER DETERMINED THAT THE ISSUE WAS RESOLVED AFTER INSTALLATION OF THE REPLACEMENT PARTS. PER HEMO-6373 MERGE HEMO 10 USER MANUAL: (PAGE 365) PROBLEM AN APPLICATION (THE HEMODYNAMICS APPLICATION OR AN EXTERNAL APPLICATION) IS FROZEN. RESOLUTION PRESS CTRL+ALT+DELETE AND CLICK TASK MANAGER. FIND APPLICATION IN THE APPLICATIONS LIST AND CLICK END TASK. IT MAY TAKE SEVERAL SECONDS FOR THE TASK TO BE STOPPED. RESTART APPLICATION TO RESUME. (PAGE 368) PROBLEM INVASIVE PRESSURE READINGS AND WAVEFORMS ARE NOT DISPLAYED ON THE HEMO MONITOR. SOLUTION POSSIBLE SOLUTIONS INCLUDE PROPER CONNECTION OF THE TRANSDUCER CABLE INTO THE PDM FOR THE NECESSARY PRESSURE CHANNEL, THE TRANSDUCER CABLE CONNECTION INTO THE CUSTOMER-SUPPLIED TRANSDUCER, AND THE INTEGRITY OF THE AIR-FREE LINE TO ENABLE A MEASUREMENT FROM THE MOST DISTAL CATHETER LOCATION TO THE HEMO SCREEN. ENSURE THE CORRECT PRESSURE CHANNEL IS SELECTED FOR DISPLAY, AND ON THE CORRECT SCALE. ADDITIONALLY, FLUID SUCH AS SALINE OR CONTRAST AT A CONNECTION POINT MAY COMPROMISE A SECURE FIT OR PROVIDE ERRONEOUS VALUES FOR DISPLAY. CONSIDER REPLACING: 1. TRANSDUCER CABLE FROM PDM, 2. CUSTOMER-SUPPLIED TRANSDUCER KIT, OR CHECKING PLACEMENT OF STOPCOCKS TO 'OPEN' OR 'CLOSED' AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    MERGE TECHNICAL SUPPORT SHIPPED REPLACEMENT HARDWARE, (RMA (B)(4)), TO THE CUSTOMER. THE FAULTY HEMO PC UNIT WAS RETURNED TO MERGE HEALTHCARE BY THE CUSTOMER AND WAS RECEIVED ON (B)(6)2017 FOR EVALUATION. THE RESULTS OF THE RETURNED HARDWARE INVESTIGATION ARE STILL IN PROCESS. THEREFORE CONCLUSION WAS SELECTED AS THE INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    MERGE HEMODYNAMICS MONITORS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS AND EVALUATIONS ARE REGISTERED AND CALCULATED IN THE PATIENT DATA MODULE. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE MERGE HEMODYNAMICS HEMO MONITOR PC. ON (B)(6) 2017, A CUSTOMER REPORTED TO MERGE HEALTHCARE THAT THEIR BOOM MONITOR WAS FLICKERING AND NOT DISPLAYING VITALS AS EXPECTED. MERGE HEALTHCARE TECHNICAL SUPPORT INVESTIGATED THE CUSTOMER'S ISSUE. REPLACEMENT CABLES AND MONITOR CONNECTION HARDWARE WERE SENT TO THE CUSTOMER. ON (B)(6) 2017 THE CUSTOMER REPORTED TO MERGE HEALTHCARE THAT THE HEMO PC HAD FROZEN DURING A PROCEDURE. THE COMPUTER WAS REBOOTED WHICH RESULTED IN A LOSS OF MONITORING PATIENT VITALS. AFTER REBOOT THE HEMO PC BEGAN OPERATING AS EXPECTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. WITH MERGE HEMO NOT CAPTURING PHYSIOLOGICAL DATA, THERE IS A POTENTIAL FOR A DELAY IN TREATMENT THAT COULD RESULT IN HARM TO A PATIENT. HOWEVER, THERE IS NO REPORT OF ANY ADVERSE EVENT OR HARM OCCURRING TO THE PATIENT AS A RESULT OF THIS ISSUE. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446505 MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER DQK MERGE HEALTHCARE MERGE HEMODYNAMICS 10.0.1

    Patients

    Seq Age Sex Outcome Treatment
    1