BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENTAL, CENTRIMAG MOTOR

    MDR report key: 19958244 · Received August 11, 2024

    Report

    Report Number
    3003306248-2024-04399
    Event Type
    Malfunction
    Date Received
    August 11, 2024
    Date of Event
    July 24, 2024
    Report Date
    October 7, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    05415067032034
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF AN M4: MOTOR ALARM WITH A RATTLING SOUND WAS CONFIRMED VIA THE LOG FILE AND VIA THE MOTOR¿S TESTING. THE LOG FILE CAPTURED SEVERAL M4 ALARMS ON 24JUL2024 ACROSS VARIOUS SET SPEEDS; AVAILABLE INFORMATION INDICATES THAT THE SYSTEM WAS NOT IN PATIENT USE AT THIS TIME. THE ALARMS INTERMITTENTLY ACTIVATED AND CLEARED THROUGHOUT THE DATA. THE RETURNED CENTRIMAG MOTOR (SERIAL NUMBER (B)(6)) WAS FUNCTIONALLY TESTED, AND M4 ALARMS WITH A RATTLING SOUND WERE REPRODUCED UPON MANIPULATING THE MOTOR¿S CABLE AT ITS BEND RELIEF. THE MOTOR WAS ABLE TO OPERATE ACROSS VARIOUS SET SPEEDS DESPITE THE ISSUES. THE MOTOR¿S CABLE WAS MEASURED, AND ONE OF ITS POWER LINES WAS OBSERVED TO BE OPEN WHICH WOULD CAUSE THE REPRODUCED EVENTS TO OCCUR. THE MOTOR¿S LEMO CONNECTOR WAS OPENED, AND ITS BROWN POWER WIRE WAS FOUND TO HAVE NOT BEEN SOLDERED TO THE CONNECTOR PROPERLY, RESULTING IN THE OPEN LINE. THE WHITE POWER WIRE, WHICH IS ALSO ASSOCIATED WITH THE OPEN LINE, WAS ALSO OBSERVED TO BE PARTIALLY DAMAGED AT THE SOLDER JOINT. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO HAVE BEEN AN IMPROPER SOLDER CONNECTION OF THE BROWN AND WHITE POWER WIRES WITHIN THE LEMO CONNECTOR ASSEMBLY. THIS ISSUE WAS PREVIOUSLY IDENTIFIED AND HAS BEEN ADDRESSED VIA A MANUFACTURING ANALYSIS TASK, AND A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS INITIATED TO INFORM THE SUPPLIER. CENTRIMAG MOTOR (B)(6) WAS MANUFACTURED PRIOR TO THE SCAR BEING INITIATED. REVIEW OF THE DEVICE HISTORY RECORD FOR 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 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 SECTION 12.1 ENTITLED "APPENDIX I ¿ CONSOLE ALARMS AND ALERTS" CONTAINS A LIST OF CONSOLE ALARMS AND ALERTS, INCLUDING MOTOR-RELATED ALARMS, AS WELL AS APPROPRIATE OPERATOR RESPONSE TO THESE EVENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PERFUSIONIST PRIMED THE CENTRIMAG EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WITHOUT ISSUE AND THEN CLAMPED THE LINE AT AN RPM GREATER THAN 2000. AN M4 ALARM OCCURRED AND THE CENTRIMAG MOTOR STARTED MAKING A SIGNIFICANT RATTLING NOISE. THE PERFUSIONIST CLAMPED, REMOVED, AND RESEATED THE PUMP WITH NO IMPROVEMENT. THE M4 ALARM WOULD NOT SILENCE OR CLEAR. THE MOTOR AND CONSOLE WERE EXCHANGED. THIS OCCURRED BEFORE THE CENTRIMAG WAS ON A PATIENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE ALARMS RESOLVED FOLLOWING THE MOTOR AND CONSOLE EXCHANGE. THE DISPOSABLE PUMP HEAD WAS NOT EXCHANGED AND WORKED JUST FINE WITH THE NEW EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1779819 RENTAL, CENTRIMAG MOTOR BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH L102956 7292649 05415067032034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown