BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS

    MDR report key: 20147979 · Received September 5, 2024

    Report

    Report Number
    3003306248-2024-04430
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    August 19, 2024
    Report Date
    January 31, 2025
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140030
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO THE CENTRIMAG CONSOLE; NO DEVICE ISSUES WITH THE CENTRIMAG BLOOD PUMP, LOT NUMBER 9008001, WERE IDENTIFIED THROUGH THIS EVALUATION. THE CENTRIMAG BLOOD PUMP WAS NOT RETURNED FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR 9008001 (L08158-LA1) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. 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

    B5 NARRATIVE INFO. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER WAS SETTING UP THE BLOOD PUMP FOR USE AND WHILE ON A PATIENT, THE ITEM FAILED ON BATTERY. THE USER STATED THAT IT APPEARED TO BE SWITCHING BETWEEN ALTERNATING CURRENT (AC) AND DIRECT CURRENT (DC) POWER AND ALARMING, HOWEVER, THE DEVICE WAS NOT SWITCHING ON FOR USE. THE USER SWAPPED THE BLOOD PUMP FOR ANOTHER.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS GETTING A COMPUTED TOMOGRAPHY (CT) SCAN AT THE TIME OF THE EVENT. EXCHANGING TO THE BACKUP PUMP RESOLVED THE ISSUE. THE PUMP EXCHANGE WAS DONE WITHIN 10 SECONDS AND THERE WAS NO KNOWN IMPACT ON PATIENT RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836395 CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS QNR THORATEC SWITZERLAND GMBH 201-90010 9008001 07640135140030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown