BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

    MDR report key: 12077093 · Received June 28, 2021

    Report

    Report Number
    3003306248-2021-02975
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 1, 2021
    Report Date
    August 31, 2021
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWA
    UDI-DI
    07640135140702
    PMA / PMN Number
    K131179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE CENTRIMAG 2ND GENERATION PRIMARY CONSOLE (SERIAL #: (B)(6)) AND THE CONSOLE WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL SECTION 4 ENTITLED "WARNINGS & PRECAUTIONS" WARNS "ONE ADDITIONAL 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, MOTOR AND FLOW PROBE ARE REQUIRED AS BACKUP SYSTEM IN THE IMMEDIATE VICINITY OF EACH PATIENT WHENEVER THE CENTRIMAG OR PEDIVAS BLOOD PUMP IS USED. THE BACKUP CONSOLE MUST BE CONNECTED TO THE BACKUP MOTOR AND TO THE BACKUP FLOW PROBE, HAVE A BATTERY CHARGE SUFFICIENT FOR AT LEAST ONE HOUR OF OPERATION, BE CONNECTED TO AC POWER (EXCEPT DURING TRANSPORT) AND BE IMMEDIATELY AVAILABLE SHOULD THE MAIN CONSOLE, MOTOR OR FLOW PROBE EXPERIENCE A MALFUNCTION." THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL SECTION 10 ENTITLED "EMERGENCY AND TROUBLESHOOTING" STATES THAT "THE RECOMMENDED PRACTICE WHENEVER THERE IS A 2ND GENERATION CENTRIMAG PRIMARY CONSOLE OR MOTOR MALFUNCTION IS TO REPLACE THE CONSOLE AND MOTOR AS A SET. REMOVE THE BLOOD PUMP FROM THE MALFUNCTIONING MOTOR AND CONSOLE AND PLACE THE BLOOD PUMP IN THE BACKUP MOTOR AND CONSOLE TO CONTINUE PATIENT SUPPORT. DO NOT EXCHANGE INDIVIDUAL MOTORS OR INDIVIDUAL CONSOLES DURING PATIENT SUPPORT." INCIDENTAL FINDING: DAMAGED TOP HOUSING. THE CONSOLE HOUSING DAMAGE COULD HAVE LEAD TO CONNECTION PROBLEMS BETWEEN CM CONSOLE AND MONITOR. THE REPORTED EVENT OF THE CONSOLE NOT COMMUNICATING WITH THE MONITOR WAS CONFIRMED. THE CENTRIMAG 2ND GENERATION PRIMARY CONSOLE (SERIAL #: (B)(6)) WAS RETURNED FOR ANALYSIS. THE REPORTED EVENT WAS ABLE TO BE DUPLICATED AND VERIFIED. THE CONSOLE WAS CONNECTED TO WORKING TEST EQUIPMENT AND WAS UNABLE TO COMMUNICATE WITH THE MONITOR; THE MONITOR SCREEN WAS BLANK. THE CONSOLE WAS OPENED AND A LOOSE CONNECTION BETWEEN THE MONITOR LEMO CONNECTOR CABLE TO THE IFD PRINTED CIRCUIT BOARD (PCB) WAS FOUND. THE CONNECTION WAS MADE SECURELY, RESOLVING THE COMMUNICATION ISSUES. A FULL FUNCTIONAL CHECKOUT WAS PERFORMED AND PASSED ALL TESTS. A MANUFACTURING ANALYSIS TASK WAS CREATED TO INVESTIGATE THE INTERNAL LOOSE CONNECTION CAUSING COMMUNICATION ISSUES BETWEEN THE CONSOLE AND THE MONITOR. THE ISSUE COULD NOT BE CORRELATED TO A MANUFACTURING ISSUE AND NO FURTHER ACTIONS WERE TAKEN. ADDITIONAL PROVIDED INFORMATION STATED THAT THE CONSOLE WAS NOT BEING USED ON THE PATIENT AT THE TIME OF THE EVENT. THE ISSUE WAS DISCOVERED WHILE PRIMING A SETUP. MULTIPLE GOOD FAITH EFFORTS WERE SENT TO RETRIEVE ADDITIONAL INFORMATION ON IF THE REPORTED EVENTS RESOLVED FOLLOWING THE CONSOLE EXCHANGE; HOWEVER, NO RESPONSE WAS RECEIVED. THE ROOT CAUSE FOR THE REPORTED EVENT WAS CONCLUSIVELY DETERMINED TO BE DUE TO AN INTERNAL LOOSE CONNECTION INSIDE OF THE CONSOLE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CENTRIMAG CONSOLE WAS NOT COMMUNICATING WITH THE MONITOR. SEVERAL MONITORS WERE HOOKED UP TO THE CONSOLE, HOWEVER IT WAS NOT SENDING ANY DATA OVER TO THE SCREEN. THE ISSUE WAS DISCOVERED DURING PRIMING, THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973242 CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA THORATEC SWITZERLAND GMBH 201-90411 6669909 07640135140702

    Patients

    Seq Age Sex Outcome Treatment
    1