BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG BLOOD PUMP

    MDR report key: 22998571 · Received September 8, 2025

    Report

    Report Number
    2916596-2025-05648
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    August 1, 2025
    Report Date
    January 8, 2026
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140627
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: DEVICE LOT NUMBER WERE NOT PROVIDED, AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. 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: A DIRECT CORRELATION BETWEEN THE CENTRIMAG BLOOD PUMP AND THE REPORTED EVENT OF CARDIAC ARRHYTHMIA COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. ADDITIONALLY, THE REPORTED EVENT OF PUMP SPEED DECREASING TO ZERO REVOLUTIONS PER MINUTE (RPM) COULD NOT BE CONFIRMED BASED ON THE PROVIDED INFORMATION. A LOG FILE WAS RETRIEVED FROM THE RETURNED CENTRIMAG CONSOLE. THE FILE DID NOT CAPTURE ANY EVENTS OR DATA FROM THE REPORTED EVENT DATE OF 01AUG2025. NO NOTABLE EVENTS OR ALARMS WERE CAPTURED. THE ACCOUNT INDICATED THAT THEY DID NOT KEEP THE DISPOSABLE PRODUCT FROM THE EVENT. NO PRODUCT IS AVAILABLE FOR EVALUATION. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE CENTRIMAG BLOOD PUMP IFU, IS CURRENTLY AVAILABLE. THE SECTION TITLED "ADVERSE EVENTS" LISTS CARDIAC ARRHYTHMIAS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM. THIS IFU ALSO PROVIDES THE FOLLOWING WARNINGS AND CAUTIONS: IFU WARNING #10: FREQUENT PATIENT AND DEVICE MONITORING IS RECOMMENDED. IFU WARNING #18: IF THE PUMP¿S OPERATION IS EVER HALTED OR FLOW REDUCED, CONSIDERATION SHOULD BE GIVEN TO MONITORING AND ADJUSTMENT OF THE PATIENT¿S ANTICOAGULATION STATUS. IFU CAUTION #2: THIS DEVICE SHOULD ONLY BE USED BY PERSONS THOROUGHLY TRAINED IN EXTRACORPOREAL CIRCULATION PROCEDURES. IFU CAUTION #15: ALWAYS HAVE A BACKUP CENTRIMAG PUMP, CONSOLE, MOTOR, AND ACCESSORIES AVAILABLE FOR USE. THE CENTRIMAG¿ CIRCULATORY SUPPORT SYSTEM OPERATION MANUAL, IS CURRENTLY AVAILABLE. SECTION 4, "WARNINGS & PRECAUTIONS", WARNS "ONE ADDITIONAL CENTRIMAG CONSOLE, MOTOR, AND FLOW PROBE ARE REQUIRED AS BACKUP COMPONENTS IN THE IMMEDIATE VICINITY OF EACH PATIENT WHENEVER THE CENTRIMAG OR PEDIMAG 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.¿ SECTION 10, ¿EMERGENCY/TROUBLESHOOTING¿, PROVIDES INSTRUCTIONS ON REPLACING COMPONENTS DURING CERTAIN CIRCUMSTANCES. SECTION 12, "APPENDICES", CONTAIN LISTS OF ALL CONSOLE ALARMS AND ALERTS, AS WELL AS APPROPRIATE OPERATOR RESPONSE TO THESE EVENTS. THE LOT NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    A. PATIENT INFORMATION UPDATED. B5 NARRATIVE INFORMATION UPDATED. H6 - ADVERSE EVENT PROBLEM UPDATED. 1914 - LOW BLOOD PRESSURE/ HYPOTENSION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT ON SUPPORT WITH THE CENTRIMAG WENT INTO VENTRICULAR FIBRILLATION. THE ONLY SYMPTOM OF ARRHYTHMIA THE PATIENT EXPERIENCED WAS HYPOTENSION SINCE THE PATIENT WAS INTUBATED AND SEDATED AT THE TIME. THE PERFUSIONIST STATED THAT THE REVALUATIONS PER MINUTE (RPMS) DECREASED TO ZERO AND FLOW DECREASED WITHOUT USER ADJUSTMENT AFTER THE ARRHYTHMIA OCCURRED. THE PUMP TRANSFERRED TO ANOTHER MOTOR AND TAKEN OUT OF SERVICE. IT WAS NOTED THAT THERE WAS A RED ALARM ASSOCIATED WITH THE EVENT. THE PATIENT'S ARRHYTHMIA RESOLVED BY ITSELF WITHOUT INTERVENTION. THE TYPE OF ARRYTHMIA WAS LATER DETERMINED TO BE VENTRICULAR TACHYCARDIA, AND WAS NOT SUSTAINED. THE PATIENT DID NOT HAVE A HISTORY OF ARRHYTHMIA PRIOR TO CENTRIMAG SUPPORT, BUT THE ARRHYTHMIA WAS NOT THOUGHT TO BE DEVICE RELATED. THE PATIENT WAS NOTED TO STILL BE ADMITTED AS OF (B)(6) 2025. THE CAUSE OF THE 0 RPMS WAS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ONLY SYMPTOM THE PATIENT EXPERIENCED WAS REPORTED TO BE HYPOTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2497375 CENTRIMAG BLOOD PUMP BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH 102953 07640135140627

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| H