BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

    MDR report key: 11633670 · Received April 8, 2021

    Report

    Report Number
    3003306248-2021-01085
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 10, 2021
    Report Date
    May 25, 2021
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWA
    UDI-DI
    07640135140702
    PMA / PMN Number
    K131179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A S3 ALARM WAS CONFIRMED VIA ANALYSIS OF THE LOG FILE DOWNLOADED FROM THE RETURNED CENTRIMAG CONSOLE (SERIAL NUMBER: (B)(6)) AND INSPECTION OF THE SUBMITTED PHOTOS. THE UNIT WAS OBSERVED TO BE OPERATING THE MOTOR AROUND THE SET SPEED ON THE REPORTED EVENT DATE, (B)(6) 2021. ON (B)(6) 2021 AT 10:15 A S3 ALARM ACTIVATED CORRELATING TO A CAN BUS SEND ERROR SUB-FAULT. THE FLOW READING WAS OBSERVED TO BE 0 LPM AT THIS TIME DUE TO THE SUB-FAULT; HOWEVER, THE MOTOR SPEED WAS OBSERVED TO BE UNAFFECTED. THE ALARM WAS MUTED; HOWEVER, THE FLOW READING REMAINED BLANK DUE TO THE CAN BUS SUB-FAULT. THE SYSTEM WAS OBSERVED TO BE TAKEN OUT OF PATIENT USE ON (B)(6) 2021 AT 13:52 AND WAS NOT OBSERVED TO BE IN PATIENT USE FOR THE REMAINDER OF THE LOG FILE. NO OTHER NOTABLE ALARMS WERE OBSERVED IN THE LOG FILE. VISUAL INSPECTION OF THE SUBMITTED PHOTOS REVEALED A S3 ALARM AND BLANK FLOW ON THE CONSOLE SCREEN; THIS IS CONSISTENT WITH THE DATA OBSERVED IN THE DOWNLOADED LOG FILE. THE RETURNED CENTRIMAG CONSOLE WAS TESTED AT THE EUROPEAN DISTRIBUTION CENTER WITH KNOWN WORKING TEST CENTRIMAG EQUIPMENT, AND THE CONSOLE FUNCTIONED AS INTENDED WITHOUT ANY ISSUES OR ATYPICAL ALARMS PRODUCED. S3 ALARMS WITH FLOW BLANKING CONDITIONS CAUSED BY A CAN BUS SEND ERROR SUB-FAULT WERE STATED TO RESOLVE UPON THE CONSOLE BEING POWER CYCLED. PREVENTATIVE MAINTENANCE WAS PERFORMED, AND THE SERVICED AND TESTED UNIT WAS RETURNED TO THE CUSTOMER SITE AFTER PASSING ALL TESTS PER PROCEDURE. THE ROOT CAUSE OF THE OBSERVED CAN BUS SUB-FAULT, RESULTING IN THE REPORTED EVENT, COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. REPORTS OF SIMILAR EVENTS WILL CONTINUE TO BE TRACKED AND MONITORED. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL (REV. 09) SECTION 10 ¿ ¿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 (REV. 09) SECTION 12.1 ¿ "APPENDIX I ¿ PRIMARY CONSOLE ALARMS AND ALERTS" COVER ALL ALARMS (AUDITORY AND VISUAL), INCLUDING SYSTEM ALARMS, AND THE APPROPRIATE ACTIONS TO TAKE IF THE ISSUE DOES NOT RESOLVE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THAT THE CENTRIMAG CONSOLE, SERIAL NUMBER (B)(6), 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 · 1

    RELATED MANUFACTURER REPORT NUMBER: (B)(4). IT WAS REPORTED THAT THE PATIENT WAS ON CENTRIMAG SUPPORT AND AFTER INTERNAL TRANSPORT FROM THE INTENSIVE CARE UNIT TO ANOTHER LOCATION, A SYSTEM ALERT S3 ALARM OCCURRED. THE CENTRIMAG MOTOR, CONSOLE, AND FLOW PROBE WAS EXCHANGED FOR THE BACKUP UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532342 CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA THORATEC SWITZERLAND GMBH 201-30300 07640135140702

    Patients

    Seq Age Sex Outcome Treatment
    1