BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS

    MDR report key: 22817457 · Received August 15, 2025

    Report

    Report Number
    3003306248-2025-00236
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    April 14, 2025
    Report Date
    October 22, 2025
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140030
    PMA / PMN Number
    K020271
    Removal / Correction Number
    FA-Q325-HF-2
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF A FIT ISSUE BETWEEN THE CENTRIMAG PUMP, LOT NUMBER 10659759, AND MOTOR WAS UNABLE TO BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR EVALUATION. A SPECIFIC CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE CENTRIMAG PUMP WOULD NOT BE RETURNED AS IT WAS DISCARDED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR CENTRIMAG BLOOD PUMP, LOT NUMBER 10659759 (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CENTRIMAG VENTRICULAR ASSIST DEVICE (VAD) INSTRUCTIONS FOR USE (IFU) (REV. E) IS CURRENTLY AVAILABLE AND PROVIDES THE FOLLOWING WARNINGS AND CAUTIONS: IFU WARNING #5: INTEGRITY OF THE COMPONENTS IN THE PERFUSION SYSTEM MUST BE CAREFULLY AND CONSTANTLY MONITORED BEFORE AND DURING USE. IFU CAUTION #9: ENSURE THE CENTRIMAG VAD IS PROPERLY LOCKED INTO THE MOTOR PER THE DIRECTIONS FOR USE SUPPLIED WITH THE MOTOR. IFU CAUTION #14: ALWAYS HAVE A SPARE CENTRIMAG VAD, CENTRIMAG BACK-UP CONSOLE AND SPARE EQUIPMENT READILY AVAILABLE FOR CHANGE. THE SECTIONS TITLED ¿BLOOD PUMP SETUP AND OPERATION (FOR VAS USE)¿ AND ¿BLOOD PUMP SETUP AND OPERATION (FOR ECMO USE) INSTRUCT TO INSPECT THE COMPLETE SYSTEM; DO NOT USE A MALFUNCTIONING OR DAMAGED SYSTEM. THESE SECTIONS ALSO PROVIDE INSTRUCTIONS FOR HOW TO MOUNT THE BLOOD PUMP ON THE MOTOR. THE FOLLOWING INSTRUCTIONS ARE PROVIDED: TO MOUNT THE CENTRIMAG VAD ON THE CENTRIMAG MOTOR, REMOVE THE BLOOD PUMP FROM THE INNER TRAY AND INSERT THE BLOOD PUMP INTO THE MOTOR RECEPTACLE. PLACE THE BOTTOM OF THE BLOOD PUMP INTO THE MOTOR RECEPTACLE WITH THE OUTLET PORT POSITIONED IN THE LARGE GROOVE. MATCH THE GROOVES ON THE PERIPHERY OF THE BLOOD PUMP WITH THE FITTINGS ON THE MOTOR RECEPTACLE. ROTATE COUNTERCLOCKWISE UNTIL THE BLOOD PUMP LOCKS SECURELY INTO PLACE. THREAD THE RETAINING SCREW CLOCKWISE TO SECURE IN PLACE. THE CENTRIMAG VAD MUST BE FULLY SEATED INTO THE RECEPTACLE TO FUNCTION PROPERLY. NOTE: IF THE CENTRIMAG VAD IS NOT PROPERLY SEATED AN ALARM ¿PUMP NOT INSERTED¿ WILL BE DISPLAYED ON THE CENTRIMAG CONSOLE DISPLAY. THE SECTION TITLED ¿EMERGENCY BACKUP EQUIPMENT¿ STATES THAT A BACK-UP STERILE CENTRIMAG VAD MUST BE AVAILABLE. THE CURRENT REVISION OF THE IFU CAN BE FOUND ON THE 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. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH INSERTING THE CENTRIMAG PUMP ON THE MOTOR DURING SET UP OF THE DEVICE. THE MOTOR WORKED FINE WITH THE TRAINING LOOP AND WOULD NOT BE RETURNED. THERE WAS A DELAY IN PROCEDURE DUE TO THE EVENT. THE CUSTOMER HAD TO INSERT THE PUMP INTO SEVERAL MOTORS AND TRY TO SEE IF IT WOULD FIT. THERE WAS NO ADVERSE IMPACT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225989 CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH 201-90010 10659759 07640135140030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other