BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG MOTOR, US

    MDR report key: 19716799 · Received July 10, 2024

    Report

    Report Number
    3003306248-2024-02789
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    June 20, 2024
    Report Date
    September 27, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWA
    UDI-DI
    07640135140078
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A4: PATIENT INFORMATION NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF S3 ALARMS WAS CONFIRMED VIA EVALUATION. THE CENTRIMAG MOTOR (SERIAL NUMBER (B)(6)) WAS EVALUATED AT THE SERVICE DEPOT. THE MOTOR WAS CONNECTED TO A TEST CONSOLE AND MOCK LOOP. WHILE ADJUSTING THE MOTOR SPEED TO 3500 ROTATIONS PER MINUTE (RPM), A ¿SYSTEM ALERT: S3¿ ALARM ACTIVATED. THE ISSUE WAS REPRODUCED WHEN THE MOTOR WAS TESTED WITH ANOTHER TEST CONSOLE. THE MOTOR WAS FORWARDED TO THE PRODUCT PERFORMANCE ENGINEERING (PPE) GROUP FOR FURTHER ANALYSIS. UPON ANALYSIS WITH PPE, THE MOTOR WAS CONNECTED TO A CALIBRATED TEST CENTRIMAG SYSTEM AND UPON TURNING THE SYSTEM ON, A ¿SYSTEM ALERT: S3¿ ALARM WAS ACTIVE. AN OPEN LINE CONTINUITY WAS MEASURED ON THE I2C-SCL/I2C-SDA LINE. THE MOTOR CABLE LEMO CONNECTOR WAS OPENED AND THE I2C-SCL WIRE (WHITE WIRE, POSITION 3) WAS FOUND TO NOT BE PROPERLY SOLDERED TO THE LEMO CONNECTOR. THE ROOT CAUSE FOR THE REPORTED EVENT WAS CONCLUSIVELY DETERMINED TO BE DUE TO AN IMPROPER SOLDER CONNECTION AT THE MOTOR LEMO CONNECTOR. A PREVIOUS MANUFACTURING TASK INVESTIGATED THIS ISSUE AND RESULTED IN OPENING A NON-ISSUANCE SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) TO INFORM THE SUPPLIER. THIS MOTOR WAS MANUFACTURED PRIOR TO THE INITIATION OF THE SCAR. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE CENTRIMAG MOTOR (SERIAL #: (B)(6)) AND THE MOTOR 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." THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL SECTION 12.1 ¿APPENDIX I ¿ CONSOLE ALARMS AND ALERTS¿ TABLE 16 DETAILS HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS INCLUDING S3 ALARMS. CENTRIMAG MOTOR IFU INSTRUCTS THE USER TO INSPECT THE CENTRIMAG MOTOR, CABLE, CONSOLE CONNECTOR, AND LOCKING MECHANISM FOR ANY DAMAGE PRIOR TO USE. IF ANY COMPONENT IS DAMAGED, DO NOT USE THE CENTRIMAG MOTOR. THIS DOCUMENT STATES THAT IF THE UNIT FAILS TO OPERATE ACCORDING TO THE MOTOR SPECIFICATIONS OR A CONSOLE DIAGNOSTIC ERROR INDICATES A CENTRIMAG MOTOR MALFUNCTION, IT SHOULD BE RETURNED. ADDITIONALLY, THIS DOCUMENT INSTRUCTS THE USER TO ALWAYS HAVE A SPARE CENTRIMAG MOTOR AND BACK-UP EQUIPMENT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE CENTRIMAG MOTORS HAD AN S3 ERROR CODE. RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2024-02790 (2ND MOTOR). RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2024-02791 (3RD MOTOR). . RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2024-02792 (CONSOLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314307 CENTRIMAG MOTOR, US CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA THORATEC SWITZERLAND GMBH 102956 7462369 07640135140078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown