BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG BLOOD PUMP

    MDR report key: 19854557 · Received July 29, 2024

    Report

    Report Number
    3003306248-2024-04388
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    July 9, 2024
    Report Date
    October 23, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140627
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D2B: DEVICE PRODUCT CODE CORRECTED SECTION D4: PRIMARY UDI CORRECTED SECTION D4: PREVIOUSLY PROVIDED SERIAL NUMBER WAS INCORRECT. 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. SECTION D5: OPERATOR OF DEVICE CORRECTED SECTION G2: REPORT SOURCE CORRECTED MANUFACTURER¿S INVESTIGATION CONCLUSION: NO DEVICE ISSUES WITH THE CENTRIMAG BLOOD PUMP WERE IDENTIFIED THROUGH THIS EVALUATION. THE CENTRIMAG BLOOD PUMP WAS NOT AVAILABLE FOR EVALUATION. THE CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) (REV. C) IS CURRENTLY AVAILABLE. THIS IFU ALSO PROVIDES THE FOLLOWING WARNINGS AND CAUTIONS: IFU WARNING #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.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DUE TO A MALFUNCTION OF THE MOTOR SCREW, THE PUMP WAS NOT COMPLETELY CONNECTED. A REPAIR WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015582 CENTRIMAG BLOOD PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE QNR THORATEC SWITZERLAND GMBH 102953 07640135140627

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female