BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS

    MDR report key: 19570447 · Received June 19, 2024

    Report

    Report Number
    3003306248-2024-02783
    Event Type
    Death
    Date Received
    June 19, 2024
    Date of Event
    May 10, 2024
    Report Date
    October 24, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140030
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN
    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 COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION E1: REPORTER EMAIL WAS NOT AVAILABLE. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE CENTRIMAG BLOOD PUMP, LOT NUMBER 9181666, AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED BY THE ACCOUNT AND THE BLOOD PUMP WAS NOT RETURNED FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR BLOOD PUMP, LOT NUMBER 9181666 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) LISTS MULTIPLE TYPES OF ORGAN FAILURE AND DYSFUNCTION, BLEEDING AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM. THIS IFU ALSO PROVIDES THE FOLLOWING WARNINGS AND CAUTIONS: IFU WARNING #9: POSSIBLE SIDE EFFECTS INCLUDE END ORGAN DYSFUNCTION. THIS IS A POTENTIAL SIDE EFFECT WITH ALL MECHANICAL CIRCULATORY SUPPORT SYSTEMS. IFU WARMING #10: FREQUENT PATIENT AND DEVICE MONITORING IS RECOMMENDED. 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 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.

    Additional Manufacturer Narrative · 0

    SECTION D1, BRAND NAME: CORRECTED. SECTION D4, MODEL NUMBER: CORRECTED. SECTION D4, CATALOG NUMBER: CORRECTED. SECTION D4, PRIMARY UDI NUMBER: CORRECTED. SECTION D4, EXPIRATION DATE - CORRECTED. SECTION H4 - DEVICE MANUFACTURE DATE - CORRECTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH HEARTMATE 3 AND THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS STARTED AFTER THE DEAIRING PHASE WAS COMPLETED. GIVEN THE DIFFICULT INFLOW POSITION, THE SURGEON RELOCATED OUTFLOW ANASTOMOSIS TO ALLOW DIFFERENT PUMP POSITIONS AND INFLOW ORIENTATIONS. WHEN THE PATIENT WAS READY T BE WEANED FROM THE CARDIOPULMONARY BYPASS (CPB), THE SURGEON REVIEWED THE APEX AREA FOR CONTINUOUS BLEEDING FROM THE AREA OF THE APICAL CUFF. THE APEX WITH THE PUMP WAS ELEVATED AND ADDITIONAL SUTURES WERE PLACED TO ENSURE HEMOSTATIC PLACEMENT OF THE APICAL CUFF. HOWEVER, DUE TO CONTINUOUS BLEEDING DESPITE NEW SUTURES, THE SURGEON DECIDED TO OPEN THE PUMP AND CHECK CONNECTION. THE PUMP WAS UNLOCKED AND WAS DEINSTALLED FROM THE APICAL CUFF. ADDITIONAL TISSUE BIOGLUE, SUTURES, AND FELT WERE APPLIED TO THE APICAL CUFF. WITH LIMITED OBTURATION OF THE APICAL CUFF LEFT VENTRICLE ENTRY, THERE SEEMED TO BE NO FURTHER BLEEDING AND THE PUMP WAS REINSTALLED INTO POSITION. AFTER NEW DEAIRING, THE SURGEON CONFIRMED BLEEDING WHICH WAS VISUALLY OCCURRING FROM THE AREA BETWEEN THE CUFF AND THE PUMP. THE SURGEON WAS ADVISED TO USE SUTURING WHOLES AROUND THE HM3 PUMP BODY TO STITCH THE BLOOD PUMP CLOSELY TO THE APICAL CUFF AS IT LOOKED THAT THE ROTATION OF THE PUMP, THERE COULD BE A CHANGE IN THE INTENSITY OF BLOOD LEAKAGE. AFTER TIGHTLY CONNECTING THE PUM P TO THE APICAL CUFF, CONTINUOUS BLEEDING WAS STILL OBSERVED FROM THE APICAL CUFF AREA. THE PUMP WAS THEN DISCONNECTED AND THE LOCKING MECHANISM WAS INSPECTED FOR DEFORMATION OF LOCKING BRANCHES THAT SEEMED TO BE IN SIMILAR AND SAME SHAPE IN THE LOCKED/ UNLOCKED POSITION. GIVEN THE LIMITED FURTHER OPTIONS, THE SURGEON DECIDED TO REMOVE THE PUMP, CLOSE THE APICAL INCISION WITH GORATEX PATCH AND IMPLANT BIVAD CENTRIMAG AS A BRIDGE TO URGENT TRANSPLANT. THE PUMP AND APICAL CUFF WERE REMOVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT PASSED AWAY ON (B)(6) 2024. THE CAUSE OF DEATH WAS DETERMINED TO BE A MULTIORGAN FAILURE RELATED MOSTLY TO LIVER AND BOWEL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672842 CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH 201-90010 9181666 07640135140030

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Death