BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG MOTOR, US

    MDR report key: 20028492 · Received August 22, 2024

    Report

    Report Number
    3003306248-2024-04402
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 29, 2024
    Report Date
    October 24, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140078
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    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

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE CENTRIMAG MOTOR WAS EVALUATED DUE TO THE REPORTED EVENT OF AN S1: POWER ON TEST ALARM OCCURRING ON THE CENTRIMAG CONSOLE. THE CENTRIMAG MOTOR (SERIAL NUMBER UNKNOWN) WAS NOT RETURNED FOR ANALYSIS. AVAILABLE INFORMATION INDICATES THAT NO FURTHER DETAILS REGARDING THE EVENT WERE ABLE TO BE PROVIDED, AND IT IS UNKNOWN IF A MOTOR WAS IN USE AT THE TIME OF THE EVENT. NO ISSUES REGARDING THE CENTRIMAG MOTOR WERE REPORTED, AND THE MOTOR WAS NOT CORRELATED TO THE CAUSE OF THE EVENT. THE SERIAL NUMBER OF THE CENTRIMAG MOTOR WAS NOT PROVIDED. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL (REV. M) SECTION 4 "WARNINGS AND PRECAUTIONS" WARNS "ONE ADDITIONAL 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, MOTOR AND FLOW PROBE ARE REQUIRED AS BACKUP SYSTEM IN THE IMMEDIATE VICINITY OF EACH PATIENT WHENEVER THE CENTRIMAG OR PEDIVAS BLOOD PUMP IS USED. THE BACKUP CONSOLE MUST BE CONNECTED TO THE BACKUP MOTOR AND TO THE BACKUP FLOW PROBE, HAVE A BATTERY CHARGE SUFFICIENT FOR AT LEAST ONE HOUR OF OPERATION, BE CONNECTED TO AC POWER (EXCEPT DURING TRANSPORT) AND BE IMMEDIATELY AVAILABLE SHOULD THE MAIN CONSOLE, MOTOR OR FLOW PROBE EXPERIENCE A MALFUNCTION." NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CENTRIMAG CONSOLE WAS GIVING AN S1 CODE ON STARTUP. THE CONSOLE HAD BEEN POWER CYCLED MANY TIMES WITH NO RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2272706 CENTRIMAG MOTOR, US PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE QNR THORATEC SWITZERLAND GMBH 102956 07640135140078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown