BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG MOTOR, OUS

    MDR report key: 20129198 · Received September 3, 2024

    Report

    Report Number
    3003306248-2024-04413
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 12, 2024
    Report Date
    November 21, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140061
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    SECTION D1: CORRECTED. SECTION D2B: CORRECTED. SECTION D4, MODEL NUMBER, CATALOG NUMBER, PRIMARY UDI NUMBER: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF AN S3: SYSTEM FAULT ALARM WAS NOT CONFIRMED. THE CENTRIMAG MOTOR (SERIAL NUMBER UNKNOWN) WAS NOT RETURNED FOR ANALYSIS, AND NO LOG FILES WERE ASSOCIATED WITH THE EVENT. AVAILABLE INFORMATION INDICATES THAT THE ALARM RESOLVED AFTER THE SYSTEM WAS REBOOTED AND AFTER THE MOTOR CABLE AND FLOW PROBE WERE DISCONNECTED AND RECONNECTED; AVAILABLE INFORMATION ALSO INDICATES THAT THE MOTOR WAS NOT EXCHANGED AND THAT NO FURTHER ISSUES HAD BEEN REPORTED. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE SERIAL NUMBER OF THE CENTRIMAG MOTOR WAS NOT PROVIDED. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL (REV. L) SECTION 3 "WARNINGS AND 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 (REV. L) SECTION 11.1-"APPENDIX I ¿ CONSOLE ALARMS AND ALERTS" CONTAINS A LIST OF CONSOLE ALARMS AND ALERTS, INCLUDING S3 ALARMS, AS WELL AS APPROPRIATE OPERATOR RESPONSE TO THESE EVENTS. 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 CONSOLE SHOWED AN S3 ALARM - "SYSTEM ALERT". IT WAS NOT CONNECTED TO A PATIENT AND WAS JUST SWITCHED ON TO SET UP THE TEMPORARY RIGHT VENTRICULAR ASSIST DEVICE (RVAD) CIRCUIT. ANOTHER UNIT WAS USED TO ASSIST THE PATIENT. THE ALARM ACKNOWLEDGE BUTTON WAS PRESSED BUT THE ALARM DID NOT RESOLVE. THE CONSOLE WAS REBOOTED AND THE MOTOR CABLE AND FLOW PROBE CABLE WERE DISCONNECTED AND RECONNECTED. THE ALARM RESOLVED AND THE CONSOLE WAS WORKING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701422 CENTRIMAG MOTOR, OUS CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS QNR THORATEC SWITZERLAND GMBH 201-10002 07640135140061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown