BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG BLOOD PUMP

    MDR report key: 22482855 · Received July 11, 2025

    Report

    Report Number
    3003306248-2025-00211
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    June 25, 2025
    Report Date
    September 18, 2025
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140627
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: DEVICE LOT NUMBER WAS NOT PROVIDED, SO THE EXPIRATION DATE 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

    H8 - USAGE OF DEVICE - CORRECTION. MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE REPORTED EVENTS AND THE CENTRIMAG PUMP COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2025 AND AFTER IMPLANT WAS TRANSITIONED FROM CARDIOPULMONARY BYPASS TO A CENTRIMAG PUMP FOR RIGHT VENTRICULAR ASSIST DEVICE (RVAD) SUPPORT. THE RVAD SPEED WAS SET TO 4700 REVOLUTIONS PER MINUTE WITH FLOW OF 3.7 LITERS PER MINUTE. THE PATIENT¿S HEART RATE WAS 77 BEATS PER MINUTE WITH BLOOD PRESSURE OF 76 SYSTOLIC/66 DIASTOLIC (MEAN 73) MILLIMETERS OF MERCURY (MMHG). AFTER THE OPERATION, THE PATIENT WAS FOUND TO BE UNRESPONSIVE TO COMMANDS, AND A COMPUTED TOMOGRAPHY SCAN REPORTEDLY SHOWED A MIDDLE CEREBRAL ARTERY (MCA) STROKE. A MECHANICAL THROMBECTOMY WAS PERFORMED AND WAS COMPLICATED BY BLEEDING, WHICH REQUIRED COIL EMBOLIZATION. THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2025 DUE TO THE MCA STROKE. IT WAS REPORTED THAT THE PATIENT¿S OUTCOME WAS NOT CONSIDERED TO BE DEVICE OR THERAPY RELATED, AND THE RVAD REPORTEDLY OPERATED AS INTENDED. THE CENTRIMAG PUMP WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER OF THE PRODUCT WAS NOT REPORTED. THE CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) (REV. C) LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM, INCLUDING THROMBOEMBOLISM (VENOUS OR ARTERIAL NON-CENTRAL NERVOUS SYSTEM), NEUROLOGIC DYSFUNCTION, BLEEDING, AND DEATH, UNDER ¿ADVERSE EVENTS¿. THIS IFU ALSO PROVIDES THE FOLLOWING WARNINGS AND CAUTIONS: IFU WARNING #7: IT IS INTENDED THAT SYSTEMIC ANTICOAGULATION BE UTILIZED WHILE THIS DEVICE IS IN USE. ANTICOAGULATION LEVELS SHOULD BE DETERMINED BY THE PHYSICIAN BASED ON RISKS AND BENEFITS TO THE PATIENT. IFU WARNING #10: FREQUENT PATIENT AND DEVICE MONITORING IS RECOMMENDED. IFU CAUTION #2: THIS DEVICE SHOULD ONLY BE USED BY PERSONS THOROUGHLY TRAINED IN EXTRACORPOREAL CIRCULATION PROCEDURES. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND OPERATION MANUAL CAN ALSO BE FOUND ON THE ELECTRONIC IFU PAGE OF THE ABBOTT WEBSITE. 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 PATIENT WAS ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND HAD A HISTORY OF RECENT MITRAL VALVE REPLACEMENT (MVR), STENTS, AND THROMBUS ON THE MITRAL VALVE (MV) PRE-IMPLANT. A CENTRIMAG RIGHT VENTRICULAR ASSIST DEVICE (RVAD) VIA A THIRD-PARTY CATHETER (PROTEK DUO) WAS PLACED DUE TO RIGHT VENTRICULAR (RV) DYSFUNCTION. ON (B)(6) 2025, THE PATIENT PASSED AWAY DUE TO A LARGE MID-CEREBRAL ARTERY (MCA) STROKE.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT THE MCA STROKE WAS AN MCA LESION THAT WAS FOLLOWED BY HEMORRHAGIC STROKE AFTER MECHANICAL THROMBECTOMY OF THE LEFT MIDDLE CEREBRAL ARTERY OCCLUSION, WHICH WAS COMPLICATED BY BLEEDING REQUIRING COIL EMBOLIZATION. THE STROKE WAS IDENTIFIED VIA COMPUTED TOMOGRAPHY (CT) SCAN. THE CENTRIMAG WAS NOT THOUGHT TO HAVE CONTRIBUTE TO THE MCA STROKE. THE PATIENT WAS UNRESPONSIVE TO COMMANDS POSTOPERATIVELY. THE SITE COULD NOT CONFIRM IF THERE WAS ANY MALFUNCTION OF THE OUTFLOW GRAFT BEND RELIEF THAT INDICATED WHY IT WAS NOT USED DURING LVAD IMPLANT. THE DEATH WAS NOT CONSIDERED TO BE DEVICE OR THERAPY RELATED, AND THE LVAD AND CENTRIMAG OPERATED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995710 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 41 YR Male Required Intervention| O