BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG BLOOD PUMP

    MDR report key: 19824159 · Received July 25, 2024

    Report

    Report Number
    3003306248-2024-04394
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    July 12, 2024
    Report Date
    October 28, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140627
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED, AND A DIRECT CORRELATION WITH THE CENTRIMAG BLOOD PUMP COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. A LOG FILE WAS EXTRACTED FROM THE RETURNED CONSOLE AND REVIEWED UNDER THE MOTOR INVESTIGATION; NO ATYPICAL EVENTS OR ALARMS WERE CAPTURED IN THE LOG FILE, AND THE SYSTEM OPERATED AROUND THE SET SPEED AS INTENDED THROUGHOUT THE DATA. THE CENTRIMAG PUMP WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE CENTRIMAG BLOOD PUMP, LOT #L08226-LA8, AND THE CENTRIMAG ADULT ECMO KIT (CMAEK), SERIAL #(B)(6), REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE AND PROVIDES THE FOLLOWING WARNINGS AND CAUTIONS: IFU WARNING #10: FREQUENT PATIENT AND DEVICE MONITORING IS RECOMMENDED. IFU CAUTION #15: ALWAYS HAVE A BACKUP CENTRIMAG PUMP, CONSOLE, MOTOR, AND ACCESSORIES AVAILABLE FOR USE. THE SECTION TITLED ¿EMERGENCY BACKUP EQUIPMENT¿ STATES THAT A BACKUP STERILE PUMP AND SUPPLIES TO PRIME MUST BE AVAILABLE. THE CURRENT REVISION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WITHIN 8 HOURS OF CANNULATION, MEDICAL STAFF NOTED THE MOTOR WAS PARTICULARLY HOT EVEN FOR SETTING OF RUNNING AT HIGH RPMS. THERE WAS NO EXCESSIVE CHUGGING OR CHATTER. THE PUMP APPEARED TO HAVE BEEN SEATED CORRECTLY, BIT WAS NOTED TO HAVE BEEN LOUDER THAN THOUGHT NORMAL. IT WAS AT 5000 RPM AND FLOW WAS AT 3.9 LPM. THE ISSUE RESOLVED AFTER THE MOTOR WAS EXCHANGED; IT WAS NOTED THAT THE CONSOLE WAS EXCHANGED CONCURRENT WITH THE MOTOR EXCHANGE. THE BLOOD PUMP WAS NOT EXCHANGED, AND THE NOISE LEVEL WAS DEEMED MORE ACCEPTABLE AND NORMAL AFTER THE MOTOR WAS EXCHANGED; THERE WAS NO CONCERN WITH THE PARTICULATE MATTER IN THE BLOOD PUMP. THE PATIENT STATUS WAS STABLE AND UNCHANGED. THERE WERE NO ADVERSE EVENTS NOTED.

    Description of Event or Problem · 0

    THE BLOOD PUMP IN USE DURING THIS OCCURRENCE WAS PART OF THE ABBOTT CENTRIMAG PRE-CONNECTED PACK FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366945 CENTRIMAG BLOOD PUMP BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH 100174048 L08226-LA8 07640135140627

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female