BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS

    MDR report key: 19602619 · Received June 24, 2024

    Report

    Report Number
    3003306248-2024-02787
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    June 4, 2024
    Report Date
    July 23, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140030
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION HAS BEEN 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 BLOOD PUMP, LOT NUMBER L07764-LA8, AND THE REPORTED EVENTS AND PATIENT OUTCOME COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE CENTRIMAG BLOOD PUMP, LOT # L07764-LA8 (BATCH NUMBER 8789436) REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE OUTSIDE OF UNITED STATES (OUS) CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) LIST WARNINGS AND CAUTIONS REGARDING THE USE OF THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM: IFU WARNING #9: POSSIBLE SIDE EFFECTS INCLUDE, BUT ARE NOT LIMITED TO: BLEEDING AND END ORGAN DYSFUNCTION. THESE ARE POTENTIAL SIDE EFFECTS WITH ALL MECHANICAL CIRCULATORY SUPPORT SYSTEMS. IFU WARNING #15: 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 #17: 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 #14: ALWAYS HAVE A SPARE CENTRIMAG VAD, CENTRIMAG BACK-UP CONSOLE AND SPARE EQUIPMENT READILY AVAILABLE FOR CHANGE. 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 ADMITTED ON (B)(6) 2024 FOR THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT BUT EXPERIENCED A COMPLEX POSTOPERATIVE COURSE. THE PATIENT EXPERIENCED INTEROPERATE RIGHT VENTRICLE (RV) LACERATION WHICH WAS REPAIRED WITH PLEGETTED STITCH AND A PERICARDIAL MEMBRANE PATCH OVER THE REPAIR SITE. THE PATIENT'S ASCENDING AORTA WAS NOTED TO HAVE BEEN FRAGILE AND CAUSED PROFUSE BLEEDING AND TISSUE TEARING DESPITE THE REVISION. THE FRAGILE AORTA WAS EXCISED AND PATCHED WITH A GELWEAVE GRAFT, AND LVAD OUTFLOW GRAFT WAS ANASTOMOSED TO IT. THE LVAD THEN HAD TO BE EXPLANTED AND THE SEWING CUFF WAS REDONE DUE TO THE PROFUSE BLEEDING AT THE LEFT VENTRICLE (LV) SITE NEAR THE SEWING RING. THE RV DYSFUNCTION REQUIRED RIGHT VENTRICULAR ASSISE DEVICE (RVAD) CENTRIMAG SUPPORT. HOWEVER, AFTER THE INITIAL OPTIMAL FUNCTION OF CENTRIMAG RVAD AND LVAD, THE RV SUDDENLY BECAME TENSE WITH GOOD RVAD FLOW BUT A DROP IN LVAD FLOW. THEREFORE, PATIENT WAS PUT BACK ON CARDIOPULMONARY BYPASS AND DECISION WAS THEN MADE TO CONVERT CENTRIMAG RVAD TO ECMO SUPPORT WITH TEMPORARY CHEST CLOSURE. POST-OPERATIVELY THE PATIENT'S CONDITION BECAME FURTHER COMPLICATED BY COAGULOPATHY WITH MULTIPLE LOW FLOWS. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION WAS AND WAS BROUGHT BACK TO OPERATING ROOM (OR) ON (B)(6) 2024 FOR RELOOK AND HEMOSTASIS. BLEEDING WAS NOTED PRIMARILY AT THE AORTIC ANASTOMOSIS SITE WHICH WAS REINFORCED WITH ANOTHER PLEGETTED STITCH. AN INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM (TTE) SHOWED A COLLAPSED LV AND RV CAVITIES, MILD AORTIC REGURGITATION. A CHEST WASHOUT WAS PERFORMED AND THEN REPACKED WITH TEMPORARY CLOSURE AFTER HEMOSTASIS WAS REATTEMPTED. THE PATIENT HAD PERSISTENT HEMODYNAMIC INSTABILITY DUE TO ONGOING BLEEDING DESPITE MAXIMAL INOTROPIC REQUIREMENT SINCE ADMISSION TO THE CARDIOTHORACIC INTENSIVE CARE UNIT POST-OPERATIVELY. ECMO FLOWS WERE SUBOPTIMAL AT LESS THAN 2 LPM, WHILE LVAD FLOWS WERE LESS THAN 1 LPM. THE PATIENT'S CONDITION CONTINUED TO DECLINE DESPITE MAXIMAL INOTROPIC SUPPORT. IN VIEW OF POOR PROGNOSIS, THE FAMILY DECIDED TO TERMINATE THE LVAD. THE PATIENT PASSED AWAY ON (B)(6) 2024 FOLLOWING THE WITHDRAWAL OF LIFE SUPPORT AND FILED AS A CORONER¿S CASE. NO CORONER¿S POSTMORTEM, CAUSE OF DEATH IS ISCHEMIC HEART DISEASE. LOG FILES WERE SUBMITTED FOR EVALUATION AND FOUND LOW SPEED ADVISORIES DUE TO THE PUMP SPEED BEING SET TO 4000 RPM AND THE LOW SPEED WAS SET TO 42000 RPM. THE LOG FILES SHOWED THE SPEED WAS CHANGED TO 3900 RPM AT 18:41, INTENTIONAL PUMP STOPS OCCURRED AT 18:55, AND THE DRIVELINE WAS DISCONNECTED AT 19:03.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145615 CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH 201-90010 8789436 07640135140030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening| R