BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG BLOOD PUMP

    MDR report key: 19921105 · Received August 6, 2024

    Report

    Report Number
    3003306248-2024-04398
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    May 18, 2024
    Report Date
    September 24, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140627
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE
    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: A DIRECT CORRELATION BETWEEN THE CENTRIMAG DEVICE AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. ADDITIONALLY, A SPECIFIC CAUSE FOR THE REPORTED SEPSIS AND INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. THE ECMO WAS REMOVED ON (B)(6) 2024. THE DEVICE WAS NOT RETURNED FOR EVALUATION THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR CENTRIMAG BLOOD PUMP, LOT # 9103436 (DOCUMENTS DHR CM PUMP L08148-LA5) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CENTRIMAG BLOOD PUMP US INSTRUCTIONS FOR USE REV. C LISTS HEMOLYSIS AND INFECTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM. THIS IFU ALSO PROVIDES THE FOLLOWING WARNINGS AND CAUTIONS: IFU WARNING #7: IT IS INTENDED THAT SYSTEMIC ANTICOAGULATION BE UTILIZED WHILE THE 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED TAMPONADE SYMPTOMS ON (B)(6) 2024 ASSOCIATED WITH A DROP IN LEFT VENTRICULAR ASSIST DEVICE (LVAD) FLOWS. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR EMERGENT MEDIASTINAL RE-EXPLORATION WHICH SHOWED A LARGE AMOUNT OF BLOOD AND LOTS IN THE MEDIASTINUM AND AROUND THE RIGHT ATRIUM. THE BLOOD AND CLOTS WERE EVACUATED. THE PATIENT WAS AWAKE AND FOLLOWING COMMANDS POST-OPERATION. THE PATIENT DEVELOPED SEPTIC SHOCK REQUIRING MAX DOSES OF PRESSORS AND HYPOXEMIA REQUIRING EMERGENT PLACEMENT OF VENOVENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) FOR OXYGENATION NOT FOR RIGHT VENTRICULAR SUPPORT ON (B)(6) 2024; IT WAS NOTED THAT THE ECMO WAS A CENTRIMAG. CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH) WAS STARTED ON (B)(6) 2024 DUE TO HYPERVOLEMIA AND ACIDOSIS. THE PATIENT HAD PROFOUND THROMBOCYTOPENIA LIKELY DUE TO CONSUMPTION, SEPSIS, AND ANTIBIOSIS. BLOOD CULTURES AND PSEUDOMONAS, THE PATIENT WAS TREATED WITH DAPTOMYCIN, MEROPENEM, AND MICAFUNGIN. THE ECMO WAS REMOVED ON (B)(6) 2024. THE PATIENT HAD A LEFT ARM AND LEG MALPERFUSION ON SYSTEMIC BIVALIRUDIN PER HEMATOLOGY. THE PATIENT REMAINED ON CVVH AND WAS INTUBATED. THE PATIENT PASSED AWAY ON (B)(6) 2024 AFTER THE FAMILY MADE THEM DO NOT RESUSCITATE (DNR). THE PUMP WAS WORKING APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770511 CENTRIMAG BLOOD PUMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS QNR THORATEC SWITZERLAND GMBH 102952 9103436 07640135140627

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other