BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG BLOOD PUMP

    MDR report key: 14882264 · Received July 1, 2022

    Report

    Report Number
    3003306248-2022-11275
    Event Type
    Injury
    Date Received
    July 1, 2022
    Date of Event
    June 1, 2022
    Report Date
    September 8, 2022
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    UDI-DI
    07640135140627
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENTS, AS WELL AS A DIRECT CORRELATION TO THE CENTRIMAG BLOOD PUMP COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON CENTRIMAG BLOOD PUMP, SERIAL NUMBER L07711-LA2, AND HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-031978. NO PRODUCT IS AVAILABLE FOR INVESTIGATION. THE DEVICE HISTORY RECORD FOR CENTRIMAG BLOOD PUMP LOT #L07711-LA2 WAS REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) LISTS BLEEDING, CARDIAC ARRHYTHMIA, AND VENOUS THROMBOEMBOLISM AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM 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 WARNING #19: DO NOT RESTART THE PUMP IF THE PUMP HAS BEEN STOPPED FOR MORE THAN 5 MINUTES WITHOUT ADEQUATE ANTICOAGULATION, AS THE RISK OF THROMBOEMBOLISM IS INCREASED AFTER BLOOD HAS REMAINED STAGNANT IN THE PUMP, EXTRACORPOREAL CIRCUIT, CONNECTORS, AND CANNULAE. IFU WARNING #21: USE OF THE PUMP FOR PERIODS LONGER THAN 30 DAYS MAY RESULT IN PUMP FAILURE, REDUCED PUMPING CAPACITY, EXCESSIVE BLOOD TRAUMA, AND/OR DEGRADATION OF BLOOD CONTACT MATERIALS (WITH POSSIBLE PARTICLES PASSING THROUGH THE CANNULAE TO THE PATIENT), LEAKS, AND INCREASED POTENTIAL FOR GASEOUS EMBOLI. IFU CAUTION #2: THIS DEVICE SHOULD ONLY BE USED BY PERSONS THOROUGHLY TRAINED IN EXTRACORPOREAL CIRCULATION PROCEDURES. IFU CAUTION #9: MONITOR CAREFULLY FOR ANY SIGNS OF OCCLUSION THROUGHOUT THE CIRCUIT. IFU CAUTION #15: ALWAYS HAVE A BACKUP CENTRIMAG PUMP, CONSOLE, MOTOR, AND ACCESSORIES AVAILABLE FOR USE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT REQUIRED DEFIBRILLATION WHILE IN THE OPERATING ROOM (OR) PRIOR TO RECEIVING RIGHT VENTRICULAR ASSIST DEVICE (RVAD) SUPPORT USING A CENTRIMAG. FOLLOWING RVAD PLACEMENT, THE PATIENT REQUIRED CARDIOVERSION; THE ARRHYTHMIA RESOLVED BEFORE THE PATIENT LEFT THE OR. THE PATIENT HAD A HISTORY OF ARRHYTHMIA PRIOR TO THEIR DEVICE IMPLANT. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION ON (B)(6) 2022 FOLLOWING A DECREASE IN THEIR HEMOGLOBIN LEVELS POST-OPERATIVELY ASSOCIATED WITH THE OUTPUT OF THEIR CHEST TUBE. ANOTHER BLOOD TRANSFUSION WAS GIVEN ON (B)(6) 2022 AS THEIR HEMOGLOBIN LEVELS HAD NOT YET INCREASED. THE PATIENT'S CHEST TUBE OUTPUT WAS NOTED TO BE LESS THAN 2 LITERS OVER A 24 HOUR PERIOD. ON (B)(6) 2022, THE PATIENT WAS NOTED TO HAVE A POSSIBLE ATRIAL FLUTTER WITH THEIR HEART RATE IN THE 140S. THE PATIENT WAS GIVEN ANTI-ARRHYTHMIA MEDICATION BOTH ORALLY AND INTRAVENOUSLY, AND WAS CARDIOVERTED, WHICH RESOLVED THE EVENT ON (B)(6) 2022. THE PATIENT RECEIVED ANOTHER BLOOD TRANSFUSION ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT UNDERWENT A LEFT BRACHIAL ARTERY EXPLORATION AND REPAIR. AN EXPANDING HEMATOMA AND HAND NUMBNESS WERE NOTED FOLLOWING THE PLACEMENT OF A LEFT BRACHIAL ARTERIAL LINE. THE PATIENT WAS GIVEN AN ADDITIONAL BLOOD TRANSFUSION ON (B)(6) 2022, ALTHOUGH NO ACTIVE BLEEDING WAS NOTED. ANOTHER BLOOD TRANSFUSION WAS GIVEN ON (B)(6). CENTRIMAG CONSOLE RELATED MFR# 3003306248-2022-11278.

    Description of Event or Problem · 0

    HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE RELATED MFR#: 2916596-2022-12125.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED ON 19JUL2022 THAT THE PATIENT EXPERIENCED PAIN IN THEIR LEFT UPPER EXTREMITIES ON (B)(6) 2022; A DUPLEX VENOUS SCAN WAS PERFORMED THAT CONFIRMED EVIDENCE OF AN ACUTE, NONOCCLUSIVE DEEP VENOUS THROMBUS INVOLVING A FOCAL SEGMENT OF THE LEFT INTERNAL JUGULAR VEIN. NO ACTIONS WERE TAKEN AS THE PATIENT WAS ALREADY ANTICOAGULATED. THE PATIENT'S HEMATOMA WAS CONSIDERED RESOLVED ON (B)(6) 2022. THE PATIENT EXPERIENCED AN EPISODE OF VENTRICULAR FIBRILLATION (VF) ON (B)(6) 2022; THE PATIENT WAS GIVEN ANTI-TACHYCARDIA PACING (ATP) THERAPY AND THE ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2207022 CENTRIMAG BLOOD PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM THORATEC SWITZERLAND GMBH 201-20003 07640135140627

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Life Threatening| H| R