BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG MOTOR, US

    MDR report key: 16770266 · Received April 19, 2023

    Report

    Report Number
    3003306248-2023-01921
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    April 14, 2023
    Report Date
    June 20, 2023
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    UDI-DI
    07640135140078
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INVOLVEMENT WAS REQUESTED, INFORMATION NOT YET PROVIDED. RELATED MFR # 3003306248-2023-01920. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION H6: TYPE OF INVESTIGATION: 4121 - EVENT HISTORY LOG REVIEW MANUFACTURE¿S INVESTIGATION CONCLUSION: THERE WERE INCIDENTAL FINDINGS OF IMPROPER SOLDER CONNECTION AT THE MOTOR LEMO CONNECTOR. THE REPORTED EVENT OF AN S3 ALARM ACTIVE WAS CONFIRMED VIA VISUAL ANALYSIS OF THE SUBMITTED LOG FILE AND TESTING OF THE RETURNED UNIT. THE SUBMITTED LOG FILE CONTAINED EVENTS SPANNING APPROXIMATELY 8 DAYS ((B)(6) 2023, (B)(6) 2023, (B)(6) 2023, (B)(6) 2023, (B)(6) 2023, (B)(6) 2023, (B)(6) 2023, AND (B)(6) 2023 PER THE TIMESTAMP). THE LOG FILE CAPTURED AN ATYPICAL S3 ALARM ACTIVE ON 13APR2023 AT 18:59:13 DUE TO A SF_LMC_MOTOR_IIC SUB FAULT FLAG. THE ALARM WAS MUTED AT 18:59:29, BUT DID NOT CLEAR. PUMP SPEED REMAINED AT 0 RPM WHILE THE S3 ALARM WAS ACTIVE. THERE WERE NO OTHER NOTABLE ATYPICAL ALARMS ACTIVE IN THE LOG FILE. THE CENTRIMAG MOTOR (SERIAL NUMBER (B)(6)) WAS RETURNED AND EVALUATED AT THE SERVICE DEPOT. DURING THE EVALUATION, THE REPORTED EVENT WAS CONFIRMED WHEN THE MOTOR WAS CONNECTED, AND THE MOTOR WAS FORWARDED TO PRODUCT PERFORMANCE ENGINEERING (PPE) 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 SCAR TO INFORM THE SUPPLIER. THIS MOTOR WAS MANUFACTURED PRIOR TO THE INITIATION OF THE SCAR. 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 M2, S3, F2, AND F3 ALARMS. 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A S3 ERROR CODE OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER TRIED TO CLEAR THE ALARM, BUT IT CONTINUED TO PRESENT ITSELF. THE CONSOLE AND MOTOR WERE EXCHANGED, RESOLVING ALARMS. THERE WAS NO ADVERSE PATIENT IMPACT RELATED TO SWAPPING OUT THE CONSOLE AND MOTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372766 CENTRIMAG MOTOR, US PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM THORATEC SWITZERLAND GMBH 102956 07640135140078

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male