BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG BLOOD PUMP

    MDR report key: 18635786 · Received February 2, 2024

    Report

    Report Number
    3003306248-2024-00400
    Event Type
    Injury
    Date Received
    February 2, 2024
    Date of Event
    December 26, 2023
    Report Date
    June 5, 2024
    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

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE CENTRIMAG BLOOD PUMP AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. A SPECIFIC CAUSE FOR THE REPORTED INFECTION OR SEPSIS COULD NOT BE CONCLUSIVELY DETERMINED. THE CENTRIMAG BLOOD PUMP WAS NOT RETURNED FOR EVALUATION. THE EVENTS WERE NOT CONSIDERED TO BE DEVICE RELATED, AND IT WAS REPORTED THAT THE DEVICE OPERATED AS EXPECTED. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE CENTRIMAG BLOOD PUMP, LOT #9212746/L08161-LA3 REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE US CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) LISTS BLEEDING, THROMBOEMBOLISM (VENOUS AND ARTERIAL NON-CNS), NEUROLOGIC DYSFUNCTION, INFECTION, HEMOLYSIS, CARDIAC ARRHYTHMIAS, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM UNDER ¿ADVERSE EVENTS¿. THE IFU ALSO LISTS MULTIPLE TYPES OF ORGAN FAILURE AND DYSFUNCTION (HEPATIC DYSFUNCTION, RENAL FAILURE/DYSFUNCTION, RESPIRATORY FAILURE, AND RIGHT HEART FAILURE) 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 #13: THE PUMP MUST BE HANDLED IN AN ASEPTIC MANNER UNTIL PRIMED AND CONNECTED TO A CLOSED TUBING CIRCUIT. 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. 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 COMPLETED.

    Additional Manufacturer Narrative · 0

    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 RECEIVED 43 UNITS OF PACKED RED BLOOD CELLS (RBC) BETWEEN (B)(6) 2023 FOLLOWING LEFT VENTRICULAR ASSIST DEVICE (LVAD) AND RIGHT VENTRICULAR ASSIST DEVICE (RVAD) IMPLANT ON (B)(6) 2023. THE PATIENT LEFT THE OPERATING ROOM ON (B)(6) 2023 WITH AN OPEN CHEST, FOLLOWED BY MULTIPLE DAYS OF INCREASED CHEST TUBE OUTPUT CONCOMITANT WITH A STERNAL AND LEFT THORACOTOMY CLOSURE ON (B)(6) 2023. THE PATIENT EXPERIENCED CHEST TUBE OUTPUT OVER A 24-HOUR PERIOD FROM (B)(6) 2023 OF 4360 MILLILITERS (ML), FROM (B)(6) 2023 WITH APPROXIMATE OUTPUT OF 3288 ML, FROM (B)(6) 2023, WITH APPROXIMATE OUTPUT OF 7722 ML AND FROM (B)(6) 2023, WITH APPROXIMATE OUTPUT OF 3340 ML. ADDITIONALLY, THE PATIENT UNDERWENT A RIGHT VIDEO-ASSISTED THORACIC SURGERY (VATS) PROCEDURE WITH NECESSITY OF AN INCREASED INTERCOSTAL WINDOW INCISION FOR REMOVAL OF RIGHT HEMOTHORAX ON (B)(6) 2023. LACTATE DEHYDROGENASE (LDH) RESULTS WERE NOTED TO BE 704 UNITS PER LITER (U/L) ON (B)(6) 2024.THE PATIENT WAS STARTED ON INTRAVENOUS ANTIBIOTICS ON (B)(6) 2024 FOR AN INCREASING WHITE BLOOD CELL COUNT. THERE WERE POSITIVE GRAM-POSITIVE COCCI ON PNEUMONIA PANEL AND NOTED PLEURAL EFFUSIONS/OPACITIES IN RIGHT LUNG. THE PATIENT WAS ON AN IV ANTIBIOTIC REGIMEN UNTIL (B)(6) 2024. THE PATIENT RECEIVED 1 UNIT OF RBCS ON (B)(6) 2024 FOR DECREASED HEMOGLOBIN (HGB) OF 7.6 AND CONTINUED CHEST TUBE OUTPUT THAT DID NOT EXCEED 2 LITER OVER A 24-HOUR PERIOD WAS NOTED. ON (B)(6) 2024, THE PATIENT WAS NOTED TO HAVE BLOOD TINGED OROGASTRIC TUBE OUTPUT ALONG WITH SUSPECTED GASTROINTESTINAL (GI) BLEEDING. RBC UNITS WERE GIVEN FOR HGB MANAGEMENT. THE PATIENT THEN EXPERIENCED HGB DROP OVERNIGHT, WITH THE NECESSITY OF RBC UNITS TO BE GIVEN. ON (B)(6) 2024, THE PATIENT BEGAN HAVING INCREASED HEMATOCHEZIA AND ALSO EXPERIENCED BLEEDING AT THE RIGHT GROIN CANNULA SITE THAT ACCOMMODATED THE PRE-IMPLANT TEMPORARY SUPPORT CANNULA. THE WOUND SITE WAS ATTENDED TO WITH CAUTERY AND PACKING TO RESOLVE EXCESS BLEEDING. THE PATIENT REMAINED INTUBATED ON (B)(6) 2024 WITH NECESSITY OF CONTINUED RESPIRATORY SUPPORT. THE PATIENT WAS TRANSITIONED TO TRACHEOSTOMY ON (B)(6) 2024. ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED ON (B)(6) 2024 AND SHOWED CONSISTENT BLOOD/CLOTS THROUGHOUT THE GI TRACT, NOTING CONSISTENT OOZING BUT NO ACTIVE LESIONS BEING SEEN. THE PATIENT'S HGB CONTINUED TO BE MANAGED WITH RBC UNITS BEING GIVEN AS NEEDED. ON (B)(6) 2024, THE PATIENT'S TOTAL BILIRUBIN AND ASPARTATE TRANSAMINASE (AST) LEVELS WERE NOTED AS 62.1 GRAMS PER DECILITER (GM/DL) AND 147 UNITS PER LITER (U/L) RESPECTIVELY. ON (B)(6) 2024, ALTERED MENTAL STATUS/ENCEPHALOPATHIC SYMPTOMS WERE NOTED. HEAD COMPUTED TOMOGRAPHY (CT) WAS OBTAINED, SHOWING SMALL PARAFALCINE SUBDURAL HEMATOMA WITHOUT MASS EFFECT OR NOTED HEMORRHAGING. IT WAS NOTED THAT THE PATIENT WAS ABLE TO FOLLOW COMMANDS IN ALL EXTREMITIES BUT DID NOT APPEAR ALERT OR ORIENTED. THE SAME DAY FOLLOW-UP HEAD CT SHOWED A STABLE SUBDURAL HEMATOMA. THERE WERE NO NOTED CHANGES IN PATIENT CONDITION/ANTICOAGULATION STATUS THAT COULD HAVE CONTRIBUTED TO THE SUBDURAL HEMATOMA TIMING. THE PATIENT WAS ALSO IN ACUTE LIVER FAILURE THAT MAY HAVE CONTRIBUTED TO THE ENCEPHALOPATHIC PICTURE. ON (B)(6) 2024, A PNEUMONIA PANEL AND RESPIRATORY CULTURE RETURNED WITH GRAM POSITIVE/NEGATIVE COCCI. THE PATIENT WAS STARTED ON APPROPRIATE IV ANTIBIOTIC THERAPIES. BLOOD CULTURES TAKEN ON (B)(6) 2024 RESULTED POSITIVE WITH GRAM POSITIVE AND GRAM NEGATIVE COCCI, STREPTOCOCCUS, AND MULTIPLE CANDIDA SPECIES. THE PATIENT WAS STARTED ON APPROPRIATE ANTIFUNGAL/ANTIBIOTIC IV THERAPIES FOR NOTED RESULTS. CONCOMITANTLY THE PATIENT EXHIBITED A SEPTIC PICTURE, REQUIRING CONTINUED VENTILATOR SUPPORT. A DECREASED PLATELET COUNT, HYPERBILIRUBINEMIA, DECREASED GLASGOW SCORE, AND CONTINUED VASOCONSTRICTING AGENTS WAS ALSO REPORTED. RELATED MFR 2916596-2024-00004.

    Description of Event or Problem · 0

    THERE WERE NO NOTED CHANGES IN PATIENT CONDITION/ANTICOAGULATION STATUS THAT COULD HAVE CONTRIBUTED TO SDH TIMING. PATIENT¿S CRITICAL STATE AND ANTICOAGULATION MANAGEMENT AT TIME OF EVENT DISCOVERY WERE CONSISTENT. NO SPECIFIC TREATMENT WAS INITIATED IN ASSOCIATION TO EVENT. THE PATIENT WAS UNABLE TO BE WEANED FROM VASOPRESSOR SUPPORT DURING 14 DAY POST OPERATION PERIOD. INFERIOR VENA CAVA ADHERENT THROMBUS WAS NOTED IN ABDOMINAL CT THAT WAS PERFORMED ON (B)(6) 2024. NO ASSOCIATED EMBOLIC EVENTS WERE NOTED AND ANTICOAGULATION MANAGEMENT CONTINUED AS APPROPRIATE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED CARDIAC ARRHYTHMIA ON (B)(6) 2024. THE PATIENT HAD A WIDE COMPLEX VENTRICULAR RHYTHM ON (B)(6) 2024 AND RECEIVED LIDOCAINE BOLUS. NO EFFECT WAS NOTED WITH THE PATIENT AND THEY WERE TO BE PACED AND MONITORED BY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR APPROPRIATELY. THE ARRHYTHMIA RESOLVED WITHOUT SEQUALAE ON THE SAME DAY. ON (B)(6) 2024, THE PATIENT PASSED AWAY DUE TO RIGHT HEART FAILURE. THE DEATH WAS NOT THOUGHT TO BE RELATED TO THE DEVICE OR THE IMPLANT PROCEDURE AND BOTH THE CENTRIMAG AND HEARTMATE 3 PUMPS OPERATED AS EXPECTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S COAGULOPATHY WAS MANAGED WITH IV PLATELETS AS MUCH AS POSSIBLE FOR INCREASED PLATELET GOAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274141 CENTRIMAG BLOOD PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM THORATEC SWITZERLAND GMBH 102953 9212746 07640135140627

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Life Threatening| R| H