BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 8599586 · Received May 10, 2019

    Report

    Report Number
    1828100-2019-00242
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 17, 2019
    Report Date
    October 21, 2019
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    UDI-DI
    00886799000656
    PMA / PMN Number
    K172220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED BLOCK: H6. THE REPORTED COMPLAINT WAS CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    PLEASE DISREGARD THE PREVIOUSLY SUBMITTED MEDWATCH FORMS. AFTER THE FIELD SERVICE REPRESENTATIVE (FSR) ALLOWED THE BATTERIES TO CHARGE, THE UNIT OPERATED AS INTENDED, THEREFORE, A COMPLAINT WAS NOT NEEDED.

    Additional Manufacturer Narrative · 1

    PER THE FSR, THE LOGS SHOWED THAT THE SYSTEM HAD NOT BEEN POWERED ON SINCE (B)(6) 2019. HE CHARGED THE BATTERIES OVERNIGHT AND BATTERIES PASSED RELEASE TEST. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATIONS. PER DATA LOG ANALYSIS, THE POWER MANAGER SHOWED THAT THE SYSTEM WAS POWERED UP ON (B)(6) 2018 WITH A CENTRAL CONTROL MONITOR (CCM) ATTACHED. THE NEXT TIME THE SYSTEM WAS POWERED UP IS WITHOUT A CCM ATTACHED, THEREFORE THE STORAGE START DATE WOULD NOT BE UPDATED. THE NEXT POWER UP WAS ON (B)(6) 2019, BATTERY CAPACITY STARTED AT 11/16 AND THEN GETS ADJUSTED TO 1/16 (< 1 AH). THERE WAS NO INDICATION OF A PROBLEM WITH THE SYSTEM SINCE IT FUNCTIONED AS DESIGNED.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING INSTALLATION OF THE DEVICE, THE BATTERIES WERE LESS THAN 1.0000 AMP HOURS (AH). THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394178 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 801763 00886799000656

    Patients

    Seq Age Sex Outcome Treatment
    1