BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG BLOOD PUMP

    MDR report key: 11734085 · Received April 27, 2021

    Report

    Report Number
    3003306248-2021-01102
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    March 19, 2021
    Report Date
    May 7, 2021
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    UDI-DI
    07640135140627
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE CENTRIMAG BLOOD PUMP AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD COMPLAINTS OF A HEADACHE IN THE SETTING OF HYPERTENSION FOLLOWED BY NAUSEA AND VOMITING, WHICH WAS TREATED WITH METOCLOPRAMIDE AND HYDRALAZINE. APPROXIMATELY AN HOUR LATER, THE PATIENT WAS FOUND UNRESPONSIVE. A HEAD COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND SHOWED A LARGE INTRAPARENCHYMAL HEMORRHAGE (IPH) WITH INTRAVENTRICULAR BLOOD. NEUROLOGY AND NEUROSURGERY WERE CONSULTED. THE PATIENT¿S PUPILS BECAME FIXED AND DILATED, AT WHICH TIME SURGICAL INTERVENTION WAS NO LONGER AN OPTION. THE PATIENT WAS PRONOUNCED BRAIN DEAD VIA APNEA TESTING AND CARE WAS WITHDRAWN ON (B)(6) 2021. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION, INCLUDING THE IDENTIFYING INFORMATION OF THE DEVICE AND PRODUCT RETURN STATUS, WERE SENT TO THE CUSTOMER; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED; HOWEVER, THE REPORTED EVENT AND SUBSEQUENT INVESTIGATION DO NOT INDICATE AN ISSUE WITH THE MANUFACTURE OF THE PRODUCT. THE CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) LISTS STROKE AND DEATH 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 WARMING #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

    RELATED MANUFACTURER REPORT NUMBER: 2916596-2021-01985.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT. HEARTMATE 3 LVAS, MLP-022942.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO (B)(6) MEDICAL CENTER ON (B)(6) 2021 WITH CENTRIMAG SUPPORT AND LISTED FOR A HEART TRANSPLANT ON (B)(6) 2021. WHILE WAITING FOR THEIR TRANSPLANT, THE PATIENT STARTED COMPLAINING OF A HEADACHE ON (B)(6) 2021 IN THE SETTING OF HYPERTENSION FOLLOWED BY NAUSEA AND VOMITING WHICH WAS TREATED WITH REGLAN AND IV HYDRALAZINE. ROUGHLY AN HOUR LATER, THE PATIENT WAS FOUND UNRESPONSIVE. A STAT CT (COMPUTERIZED TOMOGRAPHY) SCAN WAS PERFORMED ON (B)(6) 2021 WHICH SHOWED A LARGE IPH WITH INTRAVENTRICULAR BLOOD. NEUROLOGY AND NEUROSURGERY WERE CONSULTED. THE PATIENT'S PUPILS BECAME FIXED AND DILATED AT WHICH TIME SURGICAL INTERVENTION WAS NO LONGER AN OPTION. THE PATIENT WAS PRONOUNCED BRAIN DEAD VIA APNEA TESTING AND CARE WAS WITHDRAWN ON (B)(6) 2021. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629699 CENTRIMAG BLOOD PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM THORATEC SWITZERLAND GMBH 102953 07640135140627

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization HEARTMATE 3 LVAS