BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENTAL, CENTRIMAG MOTOR

    MDR report key: 19083345 · Received April 10, 2024

    Report

    Report Number
    3003306248-2024-00465
    Event Type
    Death
    Date Received
    April 10, 2024
    Date of Event
    March 19, 2024
    Report Date
    October 3, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140078
    Removal / Correction Number
    FA-Q318-MCS-1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION D4: CATALOG NUMBER AND UDI: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE CENTRIMAG MOTOR NOT FUNCTIONING PROPERLY WAS CONFIRMED VIA THE MOTOR¿S TESTING. THE RETURNED CENTRIMAG MOTOR (SERIAL NUMBER (B)(6)) WAS FUNCTIONALLY TESTED AND CAUSED AN M4: MOTOR ALARM TO OCCUR ACROSS MULTIPLE TEST CONSOLES. THE IMPELLER WAS ALSO NOTED TO BE VIBRATING WITHIN THE RECEPTACLE WITHIN CERTAIN SPEED RANGES. THE ISSUES ALSO INTERMITTENTLY OCCURRED UPON MANIPULATING THE MOTOR¿S CABLE AT ITS MOTOR-SIDE BEND RELIEF; HOWEVER, THE ISSUES DID NOT PREVENT THE MOTOR FROM OPERATING A MOCK LOOP AS INTENDED. THE MOTOR¿S CABLE WAS MEASURED, AND TWO OF ITS POWER LINES WERE OBSERVED TO BE OPEN WHICH FURTHER FLUCTUATED WITH THE CABLE¿S MANIPULATION, AND DAMAGE TO THESE LINES WOULD CAUSE THE MOTOR TO NOT FUNCTION PROPERLY. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE WIRE FATIGUE WITHIN THE MOTOR¿S CABLE AT ITS MOTOR-SIDE BEND RELIEF, CONSISTENT WITH REPETITIVE FLEXING OF THE CABLE OVER TIME. A CORRECTIVE ACTION WAS IMPLEMENTED TO ADDRESS WIRE FATIGUE WITHIN CENTRIMAG MOTOR CABLES, AND THIS MOTOR WAS MANUFACTURED PRIOR TO THIS IMPLEMENTATION. REVIEW OF THE DEVICE HISTORY RECORD FOR THE CENTRIMAG MOTOR, SERIAL NUMBER (B)(6), SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL (REV. M) PROVIDES INFORMATION REGARDING EMERGENCY/TROUBLESHOOTING IN SECTION 10. THE RECOMMENDED PRACTICE WHENEVER THERE IS A 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 BACK-UP MOTOR AND CONSOLE. SWITCH ALL COMPONENTS (CONSOLE, MOTOR, FLOW PROBE AND CABLES) SIMULTANEOUSLY TO CONTINUE PATIENT SUPPORT, AND THEN PERFORM TROUBLESHOOTING ON THE NON-FUNCTIONING SYSTEM, WHEN IT IS NO LONGER BEING USED FOR PATIENT SUPPORT. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL (REV. M) SECTION 12.1 ENTITLED "APPENDIX I ¿ CONSOLE ALARMS AND ALERTS" CONTAINS A LIST OF CONSOLE ALARMS AND ALERTS, INCLUDING M2 AND M4 ALARMS, 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 FOLLOWING AN ELECTIVE TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE, THE PATIENT HAD VENTRICULAR FIBRILLATION AND VENTRICULAR TACHYCARDIA AND WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION. AFTER THE PATIENT WAS INITIATED ON THE MOTOR, THERE WAS AN M4 MOTOR ALARM. THE MOTOR OPERATED AS INTENDED, EXCEPT WHEN THE MOTOR CABLE WAS MANIPULATED. WHEN THE MOTOR CABLE WAS MANIPULATED, THE BLOOD PUMP SOUNDED ¿OFF BALANCE¿ AND MADE A NOISE, AND THEN THE PATIENT FLOWS WOULD DECREASE A LITTLE. AS LONG AS THE MOTOR CABLE WAS NOT MANIPULATED, THE MOTOR WORKED. THE MOTOR WAS CHANGED OUT VERY SOON AFTER THIS ISSUE WAS NOTICED; THE PATIENT DID NOT SPEND A LOT OF TIME USING THE AFFECTED MOTOR. THE PATIENT PASSED AWAY A FEW HOURS AFTER THE MOTOR ISSUE WAS NOTED. THE DEATH WAS NOT CONSIDERED TO BE RELATED TO CENTRIMAG MOTOR FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925503 RENTAL, CENTRIMAG MOTOR PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE QNR THORATEC SWITZERLAND GMBH L102956 07640135140078

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Death