BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENTAL, CENTRIMAG MOTOR

    MDR report key: 20137972 · Received September 4, 2024

    Report

    Report Number
    3003306248-2024-04412
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 13, 2024
    Report Date
    October 28, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    05415067032034
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE CENTRIMAG MOTOR NOT FUNCTIONING AS INTENDED WAS CONFIRMED VIA THE MOTOR¿S FUNCTIONAL ANALYSIS. THE RETURNED CENTRIMAG MOTOR (SERIAL NUMBER (B)(6)) WAS OBSERVED TO HAVE A CUT IN ITS CABLE NEAR THE CENTER OF THE CABLE, REVEALING INNER WIRING. THE MOTOR WAS FUNCTIONALLY TESTED ALONGSIDE KNOWN WORKING TEST EQUIPMENT, AND ATYPICAL NOISES WERE REPRODUCED FROM THE ROTOR WITHIN THE PUMP RECEPTACLE WHILE THE MOTOR WAS IN USE WHILE OPERATING AROUND THE ~1000-2000 RPM SET SPEED RANGE. THE MOTOR WAS ABLE TO OPERATE THE MOCK LOOP AS INTENDED AT VARIOUS SET SPEEDS DESPITE THE NOISE, EVEN WHEN THE MOTOR¿S CABLE WAS MANIPULATED. THE MOTOR¿S CABLE WAS MEASURED FOR CONTINUITY, AND TWO OF THE MOTOR¿S POWER LINE MEASUREMENTS WERE OBSERVED TO BRIEFLY AND INTERMITTENTLY FLUCTUATE UPON MANIPULATING THE MOTOR¿S CABLE AT ITS DAMAGED AREA. THE ATYPICAL NOISE COULD HAVE ALSO RESULTED FROM DAMAGE TO THESE WIRES. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE MECHANICAL DAMAGE TO THE MOTOR¿S CABLE WHICH RESULTED IN DAMAGE TO ITS INNER WIRES; HOWEVER, THE ROOT CAUSE OF THIS DAMAGE WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. 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. CENTRIMAG MOTOR IFU (REV. 06) 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 DOES NOT 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. 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. 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 WAS NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385860 RENTAL, CENTRIMAG MOTOR BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH L102956 7289238 05415067032034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown