BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMAG BLOOD PUMP

    MDR report key: 22497574 · Received July 14, 2025

    Report

    Report Number
    3003306248-2025-00221
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    June 24, 2025
    Report Date
    August 18, 2025
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    007640135140627
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    SECTION B2: OUTCOMES ATTRIBUTED TO ADVERSE CORRECTED. SECTION D1: BRAND NAME CORRECTED. SECTION D4: MODEL NUMBER AND CATALOG NUMBER CORRECTED. SECTION D5: OPERATOR OF DEVICE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE CENTRIMAG BLOOD PUMP AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE ACCOUNT INDICATED THAT NO PRODUCT WILL BE RETURNED FOR EVALUATION. THE CENTRIMAG¿ BLOOD PUMP INSTRUCTIONS FOR USE (IFU), REV. A, IS CURRENTLY AVAILABLE. THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE CENTRIMAG¿ SYSTEM, INCLUDING CARDIAC TAMPONADE AND PERICARDIAL FLUID COLLECTION. THIS DOCUMENT ALSO INSTRUCTS TO MONITOR THE PATIENT'S HEMODYNAMICS AND THE CONSOLE'S FLOW DISPLAY TO ENSURE ADEQUATE BLOOD VOLUME. THE LOT NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED IN PELVIC ORGAN PROLAPSE (POP) INTENSIVE CARE UNIT (ICU) FOR CARDIAC SURGERY. THE EVENT WAS NOT CONSIDERED TO BE ASSOCIATED WITH THE EQUIPMENT, THE PATIENT HAD CARDIAC TAMPONADE RELATED TO THE SURGICAL PROCEDURE. THE PATIENT SUFFERED WITH SEVERE HEMODYNAMIC COMPROMISE REQUIRED SURGICAL REINTERVENTION. THE PATIENT UNDERWENT FURTHER SURGERY, REMAINED STABLE IN THE ICU. THE COORDINATING NURSE REPORTED THAT WHEN THE EMERGENCY STOP BUTTON WAS ACTIVATED, THE PUMP DID NOT STOP. DESPITE SEVERAL ATTEMPTS, THE EQUIPMENT CONTINUED TO OPERATE. GIVEN THIS SITUATION, THE PUMP WAS STOPPED BY MANUALLY REDUCING THE RPM. UPON INSPECTING THE EQUIPMENT, NO FAULTS WERE FOUND, AND THE CONSOLE CORRECTLY DISPLAYED THE MESSAGES RELATED TO THE EMERGENCY STOP. INSTRUCTIONS ARE PROVIDED INDICATING THAT THE BUTTON MUST BE HELD DOWN CONTINUOUSLY FOR APPROXIMATELY 5 SECONDS IN ORDER FOR THE PUMP TO STOP; OTHERWISE, IT WILL NOT STOP. DURING THE FUNCTIONAL TESTS USING A TEST CIRCUIT, IT WAS CONFIRMED THAT THE EQUIPMENT OPERATES CORRECTLY AND THAT THE REPORT ORIGINATED DUE TO IMPROPER USE BY THE RESPONSIBLE DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399754 CMAG BLOOD PUMP BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH 201-20003 007640135140627

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H| R