BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS

    MDR report key: 20340312 · Received September 30, 2024

    Report

    Report Number
    3003306248-2024-04441
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    September 6, 2024
    Report Date
    November 21, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140030
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: CLOTTING WAS UNABLE TO BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO PHOTOS WERE SUBMITTED. A DIRECT CORRELATION BETWEEN THE REPORTED EVENTS AND THE CENTRIMAG PUMP COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT UNDERWENT A CENTRIMAG PUMP REPLACEMENT DUE TO CLOT CREATION IN THE TUBING. IT WAS REPORTED THAT THERE WERE NO CHANGES TO PATIENT CONDITION OR ANTICOAGULATION STATUS THAT MAY HAVE CONTRIBUTED. IT WAS REPORTED THAT THE CENTRIMAG PUMP WILL NOT BE RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE CENTRIMAG BLOOD PUMP, LOT #9172346/L08155-LA1, REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) LISTS VENOUS THROMBOEMBOLISM AND ARTERIAL NON-CNS (NON-CENTRAL NERVOUS SYSTEM) THROMBOEMBOLISM AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE CENTRIMAG BLOOD PUMP. THE OUTSIDE OF THE UNITED STATES (OUS) CENTRIMAG VAD IFU IS ALSO AVAILABLE. THE IFU CONTAINS THE FOLLOWING ADDITIONAL WARNINGS AND CAUTIONS: 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 #1: STANDARD ANTICOAGULATION PROTOCOLS SHOULD BE FOLLOWED AND ANTICOAGULATION SHOULD BE ROUTINELY MONITORED DURING ALL PROCEDURES. THE BENEFITS OF EXTRACORPOREAL SUPPORT MUST BE WEIGHTED AGAINST THE RISK OF SYSTEMIC ANTICOAGULATION AND MUST BE ASSESSED BY THE PRESCRIBING PHYSICIAN. IFU CAUTION #10: MONITOR CAREFULLY FOR ANY SIGNS OF OCCLUSION THROUGHOUT THE CIRCUIT. IFU CAUTION #14: ALWAYS HAVE A SPARE CENTRIMAG VAD, CENTRIMAG BACK-UP CONSOLE AND SPARE EQUIPMENT READILY AVAILABLE FOR CHANGE. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND OPERATION MANUAL 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

    SECTION D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. 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 COMPLETED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO CHANGES TO PATIENT CONDITION OR ANTICOAGULATION STATUS THAT MAY HAVE CONTRIBUTED. THE CLOTTING WAS VISUALLY CONFIRMED. THE CENTRIMAG PUMP WAS REPLACED WITH A NEW TUBING CIRCUIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT REQUIRED A PUMP EXCHANGE DUE TO CLOT FORMATION IN THE TUBING OF THE CENTRIMAG BLOOD PUMP ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914919 CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH 201-90010 9172346 07640135140030

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Required Intervention