BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)

    MDR report key: 11827564 · Received May 14, 2021

    Report

    Report Number
    3003306248-2021-01116
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    May 2, 2021
    Report Date
    July 29, 2021
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A S3 ALARM AND A LOSS OF FLOW WAS CONFIRMED VIA THE LOG FILE. THE CENTRIMAG 2ND GENERATION PRIMARY CONSOLE (SERIAL #: (B)(6)) WAS RETURNED FOR ANALYSIS AND A LOG FILE WAS DOWNLOADED FOR REVIEW WITH EVENTS SPANNING APPROXIMATELY 34 DAYS (INTERMITTENTLY BETWEEN (B)(6) 2021 PER TIME STAMP). EVENTS OCCURRING ON (B)(6) 2021 TOOK PLACE DURING LAB TESTING AT ABBOTT. THE CONSOLE WAS OPERATING A MOTOR AT A SPEED OF ~3600 RPM WITH A FLOW OF ~4.0 LPM. ON (B)(6) 2021 AT 16:57:31, A ¿CAN BUS SEND ERROR¿ ACTIVATED, TRIGGERING A ¿SYSTEM ALERT: S3¿ ALARM. THE FLOW DROPPED TO 0 LPM; HOWEVER, THE MOTOR SPEED REMAINED. ¿FLOW SIGNAL INTERRUPTED: F2¿ ALARMS ACTIVATED AT 16:57:44. THE F2 ALARM WAS ABLE TO BE CLEARED, BUT CONTINUED TO ACTIVATED. THE CONSOLE WAS POWER CYCLED, CLEARING THE S3 ALARM. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. PUMP OPERATION WAS NOT AFFECTED. THE CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WAS RETURNED FOR ANALYSIS AND PREVENTATIVE MAINTENANCE WAS PERFORMED, AND THE CONSOLE OPERATED AS INTENDED, PASSING ALL TESTS. THE REPORTED EVENT WAS UNABLE TO BE REPRODUCED DURING TESTING. THE ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. 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." 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, INCLUDING S3 ALARMS. 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 WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S CONSOLE HAD A S3 ERROR ALARM WITH NO APPARENT CAUSE AND SIMULTANEOUS LOSS OF FLOW READING ON THE CONSOLE. THIS WAS ABOUT 40 MINUTES AFTER THE INITIATION OF VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV ECMO), DURING WHICH THERE WAS NO ISSUE THE ERROR CODE AND ALARMS WERE UNABLE TO BE RESOLVED. ECMO HAD TO BE TEMPORARILY CLAMPED OFF TO EXCHANGE THE PATIENT TO BACKUP CONSOLE. THE CONSOLE WITH ALARM CODE WAS SWITCHED OFF AND BACK ON LATER WHICH CLEARED THE ERROR CODE. THE PATIENT LOST 30 SECONDS OF ECMO SUPPORT DURING CONSOLE EXCHANGE AND THERE WAS A TEMPORARY DIP IN PATIENT SATURATION. RELATED MFRS #3003306248-2021-01117 AND # 3003306248-2021-01118.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722645 CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA THORATEC SWITZERLAND GMBH 201-90401 7496529

    Patients

    Seq Age Sex Outcome Treatment
    1