BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG MOTOR, OUS

    MDR report key: 20291691 · Received September 24, 2024

    Report

    Report Number
    3003306248-2024-04440
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    April 2, 2024
    Report Date
    September 24, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140061
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A4: THERE WAS NO PATIENT INVOLVED MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DAMAGE TO THE LOCKING SCREW WAS CONFIRMED VIA ANALYSIS OF THE RETURNED CENTRIMAG MOTOR (SERIAL NUMBER:(B)(6)), AS THE SCREW ON THE METAL LOCKING MECHANISM WAS OBSERVED TO BE DAMAGED UPON ARRIVAL. THE DAMAGED METAL LOCKING MECHANISM WAS REPLACED WITH A NEW LOCKING MECHANISM, RESOLVING THE ISSUE. THE DAMAGE TO THE LOCKING MECHANISM DID NOT IMPACT THE MOTOR'S ABILITY TO OPERATE AT THE SET SPEED. THE MOTOR COULD NOT REACH THE SET SPEED AND WOULD PRODUCE AN ATYPICAL NOISE DUE TO THE GRAY WIRE BECOMING DETACHED FROM THE SOLDER JOINT CONNECTING IT TO THE LEMO CONNECTOR. THIS INDICATES THAT THE WIRE WAS NOT PROPERLY SOLDER TO THE CONNECTOR . THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. 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 QA 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 SYSTEM AND 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 THE CENTRIMAG MOTOR SCREW WAS BROKEN. THE MOTOR WAS CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015988 CENTRIMAG MOTOR, OUS Blood pump for ECMO, long-term (> 6 hours) use QNR THORATEC SWITZERLAND GMBH 201-10002 8241965 07640135140061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown