BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG MOTOR, US

    MDR report key: 18907192 · Received March 14, 2024

    Report

    Report Number
    3003306248-2024-00452
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    March 11, 2024
    Report Date
    December 12, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140078
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A: NO PATIENT WAS INVOLVED. 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 THE CENTRIMAG MOTOR NOT FUNCTIONING PROPERLY WAS CONFIRMED. THE CENTRIMAG MOTOR (SERIAL NUMBER: (B)(6)) WAS TESTED AT SERVICE DEPOT. DURING TESTING IT WAS OBSERVED THAT THE IMPELLER WITHIN THE BLOOD PUMP WAS VIBRATING AND WOULD NOT CENTER. A MOTOR ALARM: M4 APPEARED ON THE CONSOLE¿S DISPLAY AND WOULD NOT CLEAR. THE MOTOR IS UNABLE TO BE REPAIRED AND WAS SHIPPED TO PRODUCT PERFORMANCE ENGINEERING (PPE) FOR FURTHER ANALYSIS. FURTHER TESTING WAS PERFORMED BY PPE. THE CENTRIMAG MOTOR WAS CONNECTED TO A TEST CONSOLE, TEST CENTRIMAG MONITOR AND MOCK LOOP. THE MOTOR CABLE WAS MANIPULATED BY HAND AND UPON MANIPULATION OF THE DISTAL BEND RELIEF, A MOTOR DISCONNECTED: M4 ALARM BECAME ACTIVE. THE RESISTANCE OF THE UNDERLYING WIRES OF THE MOTOR WERE MEASURED, AND UPON MANIPULATION OF THE CABLE NEAR THE DISTAL MOTOR BEND RELIEF AN OPEN LOOP WAS FOUND ON THE HX/Y (FIELD SIGNAL FOR BX/Y DIRECTION). THE WIRE¿S INSULATION WAS TESTED, AND EACH WIRE PASSED. THE MOTOR WAS RETURNED TO THE CUSTOMER. NO FURTHER TESTING WAS PERFORMED. MULTIPLE GOOD FAITH EFFORTS WERE SENT ASKING IF A PATIENT WAS CONNECTED TO THE DEVICE AT THE TIME OF THE EVENT TO DATE NO RESPONSE HAS BEEN PROVIDED. THE ROOT CAUSE FOR REPORTED EVENT WAS DUE TO CONDUCTOR BREAKDOWN WITHIN THE MOTOR CABLE; HOWEVER, THE ROOT CAUSE FOR THE DAMAGE WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE CENTRIMAG MOTOR (SERIAL NUMBER: L06716-0016) 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 ENTITLED "APPENDIX I ¿ PRIMARY CONSOLE ALARMS AND ALERTS" CONTAINS A LIST OF CONSOLE ALARMS AND ALERTS, AS WELL AS APPROPRIATE OPERATOR RESPONSE TO THESE EVENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE CENTRIMAG MOTOR NOT FUNCTIONING PROPERLY WAS CONFIRMED. THE CENTRIMAG MOTOR (SERIAL NUMBER: (B)(6) WAS TESTED AT SERVICE DEPOT. DURING TESTING IT WAS OBSERVED THAT THE IMPELLER WITHIN THE BLOOD PUMP WAS VIBRATING AND WOULD NOT CENTER. A MOTOR ALARM: M4 APPEARED ON THE CONSOLE S DISPLAY AND WOULD NOT CLEAR. THE MOTOR IS UNABLE TO BE REPAIRED AND WAS SHIPPED TO PRODUCT PERFORMANCE ENGINEERING (PPE) FOR FURTHER ANALYSIS. FURTHER TESTING WAS PERFORMED BY PPE. THE CENTRIMAG MOTOR WAS CONNECTED TO A TEST CONSOLE, TEST CENTRIMAG MONITOR AND MOCK LOOP. THE MOTOR CABLE WAS MANIPULATED BY HAND AND UPON MANIPULATION OF THE DISTAL BEND RELIEF, A MOTOR DISCONNECTED: M4 ALARM BECAME ACTIVE. THE RESISTANCE OF THE UNDERLYING WIRES OF THE MOTOR WERE MEASURED, AND UPON MANIPULATION OF THE CABLE NEAR THE DISTAL MOTOR BEND RELIEF AN OPEN LOOP WAS FOUND ON THE HX/Y (FIELD SIGNAL FOR BX/Y DIRECTION). THE WIRE¿S INSULATION WAS TESTED, AND EACH WIRE PASSED. NO FURTHER TESTING WAS PERFORMED. ADDITIONAL INFORMATION PROVIDED ON 09APR2024 STATED NO PATIENT WAS CONNECTED AT THE TIME OF THE EVENT, AND NO TROUBLESHOOTING WAS PERFORMED. THE ROOT CAUSE FOR REPORTED EVENT WAS DUE TO CONDUCTOR BREAKDOWN WITHIN THE MOTOR CABLE; HOWEVER, THE ROOT CAUSE FOR THE DAMAGE WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE CENTRIMAG MOTOR (SERIAL NUMBER: (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 ENTITLED "APPENDIX I ¿ PRIMARY CONSOLE ALARMS AND ALERTS" CONTAINS A LIST OF CONSOLE ALARMS AND ALERTS, AS WELL AS APPROPRIATE OPERATOR RESPONSE TO THESE EVENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CABLE WAS UNABLE TO COMMUNICATE WITH THE PUMP. THE MOTOR WAS RETURNED FOR EVALUATION AND REPAIR. RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2024-00453 (CENTRIMAG PUMP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018684 CENTRIMAG MOTOR, US CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS QNR THORATEC SWITZERLAND GMBH 102956 07640135140078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown