BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS

    MDR report key: 22484726 · Received July 11, 2025

    Report

    Report Number
    3003306248-2025-00204
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    April 10, 2025
    Report Date
    July 30, 2025
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140030
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1 - PATIENT IDENTIFIER NOT PROVIDED. SECTION D4: THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION D2B: DEVICE PRODUCT CODE CORRECTED. SECTION E1: REPORTER EMAIL WAS NOT AVAILABLE. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE REPORTED EVENTS AND THE CENTRIMAG VAD COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE CENTRIMAG VAD WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE CENTRIMAG BLOOD PUMP, LOT NUMBER 9157430/L08154-LA5, REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CENTRIMAG VAD INSTRUCTIONS FOR USE (IFU) LISTS POSSIBLE SIDE EFFECTS, INCLUDING END ORGAN DYSFUNCTION AND NEUROLOGIC DYSFUNCTION. THESE ARE POTENTIAL SIDE EFFECTS WITH ALL MECHANICAL CIRCULATORY SUPPORT SYSTEMS. THIS IFU ALSO PROVIDES THE FOLLOWING WARNINGS AND CAUTIONS: 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. THE CENTRIMAG BLOOD PUMP IFU IS ALSO AVAILABLE. THIS DOCUMENT LISTS DEATH, NEUROLOGIC DYSFUNCTION, AND 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¿. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. 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 WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT HEARTMATE 3 (HM3) IMPLANTATION DUE TO VALVULAR HEART FAILURE ON (B)(6) 2025. THIS WAS COMBINED WITH A SEVERE MITRAL STENOSIS (MS) REPAIR. HYPOTENSION AND METABOLIC ACIDOSIS WERE OBSERVED, WHICH OCCURRED DURING WEANING FROM CARDIOPULMONARY BYPASS (CPB), WHICH NECESSITATED THE USE OF A CENTRIMAG RIGHT VENTRICULAR ASSIST DEVICE (RVAD). BLOOD PRESSURE WAS STILL UNSTABLE. LEVOPHED (NOREPINEPHRINE), DOPAMINE, BOSMIN (EPINEPHRINE), AND DOBUTAMINE LINES WERE SUPPORTED. VASOPLEGIA WAS SUSPECTED. POSTOPERATIVE PARAMETERS FOR THE RVAD WERE 3050 RPM WITH FLOW RATE 3.3 LPM AND 5400 RPM WITH FLOW RATE 4.7¿4.8 LPM FOR THE LVAD. THE PATIENT'S CONSCIOUSNESS WAS UNCLEAR AFTER SURGERY. AN ARRANGED BRAIN COMPUTED TOMOGRAPHY (CT) REVEALED HYPOXIC ENCEPHALOPATHY (HE). THE FAMILY DECIDED TO SIGN DO-NOT-RESUSCITATE (DNR) AND REMOVE ALL THE LIFE SUPPORT SYSTEMS. HEALTHCARE PROVIDERS (HCPS) DETERMINED THAT THE EVENT WAS NOT RELATED TO THE DEVICES, AND THE DEVICES OPERATED AS EXPECTED. THE CAUSE OF DEATH WAS MULTIPLE ORGAN FAILURE. THE MULTIPLE ORGAN FAILURE WAS THOUGHT TO NOT BE RELATED TO THE DEVICE. NO PRODUCTS WOULD BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894685 CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS VENTRICULAR (ASSIST) BYPASS QNR THORATEC SWITZERLAND GMBH 201-90010 9157430 07640135140030

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other| R