BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

    MDR report key: 11985054 · Received June 11, 2021

    Report

    Report Number
    3003306248-2021-02972
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 12, 2021
    Report Date
    October 29, 2021
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWA
    PMA / PMN Number
    K131179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE CENTRIMAG 2ND GENERATION PRIMARY CONSOLE IS BEING EVALUATED FOR THE REPORTED EVENT OF THE FLOW PROBE NOT READING. THE CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WAS NOT RETURNED FOR ANALYSIS. ADDITIONAL PROVIDED INFORMATION COMMUNICATED ON 12AUG2021 STATED THAT THE ISSUE WAS ONLY WITH THE FLOW PROBE. THE SERIAL NUMBER OF THE MOTOR AND CONSOLE WAS UNABLE TO BE PROVIDED UPON REQUEST. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL SECTION 4 ENTITLED "WARNINGS & PRECAUTIONS" WARNS "ONE ADDITIONAL 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, MOTOR AND FLOW PROBE ARE REQUIRED AS BACKUP SYSTEM IN THE IMMEDIATE VICINITY OF EACH PATIENT WHENEVER THE CENTRIMAG OR PEDIVAS BLOOD PUMP IS USED. THE BACKUP CONSOLE MUST BE CONNECTED TO THE BACKUP MOTOR AND TO THE BACKUP FLOW PROBE, HAVE A BATTERY CHARGE SUFFICIENT FOR AT LEAST ONE HOUR OF OPERATION, BE CONNECTED TO AC POWER (EXCEPT DURING TRANSPORT) AND BE IMMEDIATELY AVAILABLE SHOULD THE MAIN CONSOLE, MOTOR OR FLOW PROBE EXPERIENCE A MALFUNCTION." . THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL SECTION 10 ENTITLED "EMERGENCY AND TROUBLESHOOTING" STATES THAT "THE RECOMMENDED PRACTICE WHENEVER THERE IS A 2ND GENERATION CENTRIMAG PRIMARY 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 BACKUP MOTOR AND CONSOLE TO CONTINUE PATIENT SUPPORT. DO NOT EXCHANGE INDIVIDUAL MOTORS OR INDIVIDUAL CONSOLES DURING PATIENT SUPPORT.". THE DEVICE HISTORY RECORDS WERE UNABLE TO BE REVIEWED DUE TO THE SERIAL NUMBER OF THE CONSOLE BEING UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT INFORMATION WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERFUSIONIST NOTICED THAT THE FLOW PROBE WAS NOT READING. THE FLOW PROBE WAS READJUSTED AS WELL AS UNPLUGGED AND THEN RE-PLUGGED IN WITH NO RESOLUTION TO THE PROBLEM. THE SYSTEM WAS CHANGED OUT SUCCESSFULLY. RELATED MANUFACTURER NUMBER OF FLOW PROBE: 3003306248-2021-02970. RELATED MANUFACTURER NUMBER OF MOTOR: 3003306248-2021-02971.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877863 CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA THORATEC SWITZERLAND GMBH 201-90411

    Patients

    Seq Age Sex Outcome Treatment
    1