BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG MOTOR, OUS

    MDR report key: 19802460 · Received July 22, 2024

    Report

    Report Number
    3003306248-2024-04382
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    July 4, 2024
    Report Date
    October 29, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140061
    PMA / PMN Number
    K020271
    Removal / Correction Number
    FA-Q318-MCS-1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A4: THERE WAS NO PATIENT 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 A M4: MOTOR ALARM WAS CONFIRMED VIA ANALYSIS OF THE RETURNED CENTRIMAG MOTOR. VISUAL INSPECTION OF THE RETURNED CENTRIMAG MOTOR (SERIAL NUMBER: (B)(6)) REVEALED THAT THE CONNECTOR CAP WAS DAMAGED. NO OTHER PHYSICAL ANOMALIES WERE OBSERVED. THE RETURNED CENTRIMAG MOTOR WAS EVALUATED BY SERVICE DEPOT AND BY PRODUCT PERFORMANCE ENGINEERING ALONGSIDE KNOWN WORKING TEST CENTRIMAG EQUIPMENT AND A MOCK CIRCULATORY LOOP. DURING TESTING, IT WAS ATTEMPTED MULTIPLE TIMES TO INCREASE THE MOTOR¿S SET SPEED; HOWEVER, THE MOTOR SPEED COULD NOT BE ADJUSTED AND M4: MOTOR ALARM AND M2: MOTOR DISCONNECTED ALARMS WOULD ACTIVATE. THE CONTINUITY OF THE WIRES IN THE MOTOR CABLE WERE THEN INDIVIDUALLY TESTED, REVEALING THAT THE BLUE AND YELLOW (DRIVE PHASE) WIRES WERE DAMAGED. A SECTION OF THE MOTOR CABLE¿S OUTER JACKET AT THE PROXIMAL BEND RELIEF WAS REMOVED TO INSPECT THE UNDERLYING WIRES, REVEALING THAT THE INSULATION ON THE BROWN (POSITION SIGNAL), BLUE, AND YELLOW WIRES WERE TORN, EXPOSING THE INNER CONDUCTORS. INSPECTION OF THE WIRES REVEALED THAT THE EXPOSED INNER CONDUCTORS COULD HAVE SHORTED TO THE SHIELDING, WHICH WOULD RESULT IN THE REPORTED EVENT. THE REPORTED EVENT WAS DETERMINED TO BE DUE TO WIRE FATIGUE IN THE RETURNED MOTOR CABLE. ALTHOUGH NOT CONCLUSIVELY DETERMINED, REPETITIVE FLEXING OF THE BEND RELIEF DURING USE OVER TIME MAY HAVE CONTRIBUTED TO THE OBSERVED UNDERLYING WIRE DAMAGE. SIMILAR REPORTS OF CONDUCTOR BREAKDOWN IN THE MOTOR¿S CABLE HAVE BEEN DOCUMENTED, AND A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS IMPLEMENTED TO ADDRESS THE WIRE FATIGUE. THE RETURNED MOTOR WAS MANUFACTURED PRIOR TO THE IMPLANTATION OF THE CAPA. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THAT THE CENTRIMAG MOTOR, SERIAL NUMBER (B)(6), WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL SECTION 9 ¿ ¿EMERGENCIES/TROUBLESHOOTING¿ PROVIDES INSTRUCTIONS FOR OPERATION WHEN THERE IS A NEED TO EXCHANGE THE MAIN CONSOLE OR MOTOR WITH A BACKUP CONSOLE OR MOTOR. 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 SECTION 11.1 ¿ "APPENDIX I ¿ PRIMARY CONSOLE ALARMS AND ALERTS" COVER ALL ALARMS (AUDITORY AND VISUAL), INCLUDING MOTOR ALARMS, AND THE APPROPRIATE ACTIONS TO TAKE IF THE ISSUE DOES NOT RESOLVE. CENTRIMAG MOTOR INSTRUCTIONS FOR USE INSTRUCTS THE USER TO INSPECT THE CENTRIMAG MOTOR, CABLE, CONSOLE CONNECTOR, AND LOCKING MECHANISM FOR ANY DAMAGE PRIOR TO USE. IF ANY COMPONENT IS DAMAGED, DO NOT USE THE CENTRIMAG MOTOR. THIS DOCUMENT STATES THAT IF THE UNIT FAILS TO OPERATE ACCORDING TO THE MOTOR SPECIFICATIONS OR A CONSOLE DIAGNOSTIC ERROR INDICATES A CENTRIMAG MOTOR MALFUNCTION, IT SHOULD BE RETURNED. ADDITIONALLY, THIS DOCUMENT INSTRUCTS THE USER TO ALWAYS HAVE A SPARE CENTRIMAG MOTOR AND BACK-UP EQUIPMENT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A REGULAR CHECK BY THE ENGINEER TEAM, THE CONSOLE SHOWED EITHER AN S1 OR B1 ERROR. IT WAS NOTED THAT THE ENGINEER TEAM COULD NOT VERIFY WHICH CONSOLE ALARM WAS ACTIVE AS THE ALARM WAS NOT CLEAR. THE MOTOR WAS GENERATING A M4 ERROR WHEN HOOKED UP. THE UNIT WAS HELD FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004964 CENTRIMAG MOTOR, OUS BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH 201-10002 07640135140061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown