BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG MOTOR

    MDR report key: 20230853 · Received September 16, 2024

    Report

    Report Number
    3003306248-2024-04424
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 23, 2024
    Report Date
    November 12, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140078
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A: PATIENT INFORMATION WAS REQUESTED BUT COULD NOT BE PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION D1: CORRECTED. SECTION D4, PRIMARY UDI NUMBER: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE CENTRIMAG SYSTEM STOPPING UNEXPECTEDLY WAS CONFIRMED VIA THE LOG FILE THAT WAS EXTRACTED FROM THE RETURNED CONSOLE DURING TESTING. THE LOG FILE CAPTURED THE SYSTEM STOPPING 3 TIMES ON (B)(6) 2024, OCCURRING AT 16:17:20, 16:20:20, AND 16:53:58. ALTHOUGH THE CAUSES OF THE STOPS WERE UNABLE TO BE CONCLUSIVELY DETERMINED FROM THE LOG FILE ALONE, EACH STOPPAGE CORRELATED TO A ¿PUMP STOPPED DUE TO USER REQUEST¿ FLAG WITH INDICATIONS OF THE PUMP STOP BUTTON BEING HELD FOR 5 SECONDS. THE SYSTEM¿S SET SPEED WAS RAMPED BACK UP TO INTENDED VALUES WITHIN THE SAME MINUTES OF EACH PUMP STOP, AND THE SYSTEM OPERATED AS INTENDED THROUGHOUT THE REMAINDER OF THE DATA. THE RETURNED CENTRIMAG MOTOR (SERIAL NUMBER (B)(6)) WAS FUNCTIONALLY TESTED AT THE SERVICE DEPOT AND PERFORMED AS INTENDED THROUGHOUT ALL TESTING. ATYPICAL EVENTS WERE UNABLE TO BE REPRODUCED, AND THE SERVICED AND TESTED MOTOR WAS RETURNED TO THE CUSTOMER SITE AFTER PASSING ALL TESTS PER PROCEDURE. AVAILABLE INFORMATION INDICATES THAT THE PUMP STOP BUTTON WAS NOT BEING DEPRESSED AT THE TIME OF THE EVENTS. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. 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. 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 6.7.3 ¿FEATURES OF THE CONSOLE, MONITOR, AND FLOW PROBES¿) INSTRUCTS USERS HOW TO STOP THE PUMP USING THE EMERGENCY PUMP STOP BUTTON. AN AUDIO ALARM WILL SOUND WHILE THE KEYPAD IS DEPRESSED, INDICATING THAT THE PUMP WILL BE STOPPED SOON. 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 SYSTEM HAD A SUDDEN PUMP STOPPAGE TWICE WITHIN 5 MINUTES. THE SITE STATED THAT EACH OCCURRENCE, THE ¿HOLD TO STOP PUMP¿ AUDIO WAS HEARD, HOWEVER, THE HOLD TO STOP BUTTON WAS NOT BEING DEPRESSED. THIS EVENT OCCURRED ON 26JUN2024 AS WELL HOWEVER, IT WAS DEEMED TO BE USER ERROR AND INCIDENTAL AS THE DATA LOGGER REVIEW SHOWED THE PUMP WAS STOPPED DUE TO USER REQUEST. AT THAT TIME, THERE WAS NO CONCERN FOR DAMAGE OR DEFICIENCY IN HARDWARE. AFTER INITIAL PUMP STOPPAGE, THE RPMS AND SUBSEQUENT FLOWS WERE IMMEDIATELY RESTORED BY THE CLINICIAN. AFTER THE SECOND OCCURRENCE, THE PUMP WAS RE-SEATED. THE TEAM THEN DECIDED IT WOULD BE SAFEST TO SWITCH OVER TO BACK-UP HARDWARE TO SEND FAULTY EQUIPMENT IN FOR INSPECTION. NO ALARMS OR ALERTS WERE PRESENT OR PRECIPITATED THE EVENT. PATIENT WAS NOT HARMED AND WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2532115 CENTRIMAG MOTOR BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH 102956 07640135140078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown