BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG MOTOR, OUS

    MDR report key: 11685003 · Received April 19, 2021

    Report

    Report Number
    2916596-2021-01716
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 1, 2021
    Report Date
    May 27, 2021
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    PMA / PMN Number
    K020271
    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 LOW FLOW ALARMS WAS CONFIRMED VIA THE LOG FILE. THE CENTRIMAG MOTOR (SERIAL #: (B)(6)) WAS RETURNED FOR ANALYSIS AND A LOG FILE WAS DOWNLOADED FOR REVIEW FROM THE RETURNED AND ASSOCIATED CENTRIMAG 2ND GENERATION PRIMARY CONSOLE. A REVIEW OF THE DOWNLOADED LOG FILE SHOWED EVENTS SPANNING APPROXIMATELY 4 DAYS ((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 ~3400 RPM WITH A FLOW OF ~3.3 LPM. THROUGHOUT THE LGO FILE, THE FLOW WAS SEEN SLOWING DECREASING, CAUSING ¿FLOW BELOW MINIMUM: F3¿ ALARMS BEGAN TO ACTIVATE. THE MOTOR SPEED AND THE FLOW MINIMUM THRESHOLD WERE ADJUSTED; HOWEVER, F3 ALARMS CONTINUED TO ACTIVATE. THIS SEQUENCE OF EVENTS CONTINUED TO OCCUR UNTIL THE PUMP WAS STOPPED DUE TO USER REQUEST ON (B)(6) 2021 AT 04:36:15. PUMP OPERATION WAS NOT AFFECTED. THE CENTRIMAG MOTOR WAS FUNCTIONALLY TESTED AND OPERATED AS INTENDED. THE REPORTED EVENT WAS UNABLE TO BE REPRODUCED DURING THE INVESTIGATION. PREVENTATIVE MAINTENANCE WAS PERFORMED SUCCESSFULLY. ADDITIONAL PROVIDED INFORMATION COMMUNICATED ON 13MAY2021 STATED THAT WHEN PREVIOUSLY CHECKING THE CIRCUIT, CONTINUOUS BLOOD FLOW WAS SEEN GOING THROUGH THE ARTERIAL CANNULA. WHEN THE PUMP HEAD FAILED, THIS WAS NOT EVIDENT ANYMORE; HOWEVER, IT WAS STILL IN THE VENOUS CANNULA. THE FLOW RESUMED IMMEDIATELY AFTER THE PUMP HEAD WAS CHANGED AND IT WAS VISIBLY FLOWING. IT WAS STATED THAT THERE WERE NO OTHER ISSUES THAT COULD HAVE ATTRIBUTED TO THE LOW FLOWS AS THESE WERE ALL CONSIDERED AND RULED OUT BEFORE DOING A PUMP HEAD CHANGE. THE ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL (REV. 10) 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 (REV. 10) 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 (REV. 10) 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 FLOW ALARMS AND PRESSURE 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 · 1

    IT WAS REPORTED THAT THERE WERE LOW FLOW ALARMS WHILE THE PATIENT WAS CONNECTED TO THE CENTRIMAG. THERE WAS NO CIRCUIT KINKING. P1 AND P2 PRESSURES RELATING TO THE PATIENT'S INTUBATION WERE NEGATIVE (NO DISCONNECTION). THE PATIENT'S VITAL SIGNS WERE STABLE AND THERE WAS NO INCREASE IN END-TIDAL CO2 (ETCO2) OR DESATURATION. THE PATIENT'S ARTERIAL GAS WAS UNCHANGED. THE PATIENT WAS GIVEN A FLUID BOLUS BUT LOW FLOW ALARMS CONTINUED. NORADRENALINE WAS ADMINISTERED BUT THE PATIENT STARTED BECOMING HYPERTENSIVE AND ALARMS DID NOT STOP SO IT WAS DISCONTINUED AFTER LESS THAN 10 MINUTES. THE PUMP HEAD MOTOR WAS STILL SPINNING. THE PERFUSIONIST CHANGED THE PUMP HEAD AND THE FLOWS RETURNED TO PRIOR VOLUMES IMMEDIATELY. THE PATIENT TOLERATED THE PUMP HEAD CHANGE AND PRE-OXYGENATED TO 100%. THE PATIENT WAS ON A VENTILATOR WHERE FRACTION OF INSPIRED OXYGEN (FIO2) WAS 40%, AND THERE WAS NO DESATURATION OR INCREASE IN ETCO2. THE PATIENT'S ARTERIAL GAS WAS UNCHANGED AFTER THE PROCEDURE. THERE WAS NO BLOOD MOVEMENT NOTED IN THE ARTERIAL CANNULA BUT IT WAS MOVING IN THE VENOUS CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587804 CENTRIMAG MOTOR, OUS PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM THORATEC SWITZERLAND GMBH 201-10002 7506403

    Patients

    Seq Age Sex Outcome Treatment
    1 CENTRIMAG CONSOLE WITH FLOW PROBE