BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 8265172 · Received January 21, 2019

    Report

    Report Number
    1828100-2019-00032
    Event Type
    Malfunction
    Date Received
    January 21, 2019
    Date of Event
    December 27, 2018
    Report Date
    May 20, 2019
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    UDI-DI
    00886799001325
    PMA / PMN Number
    K172220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING LABORATORY EVALUATION, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) OBSERVED NO DISPLAY WHEN POWER WAS APPLIED TO THE CENTRAL CONTROL MONITOR (CCM). IT WAS DETERMINED THAT THE POWER INVERTER PRINTED CIRCUIT BOARD (PCB) WAS THE CAUSE OF THE PROBLEM. HE ALSO FOUND THE HARD DRIVE AND EIED PCB TO BE LOOSE AND SEPARATED FROM THE VIBRATION ISOLATION MOUNTS. THE PRODUCT WILL BE SENT TO SERVICE TO BE BROUGHT TO MANUFACTURER¿S SPECIFICATIONS BEFORE BEING RETURNED TO THE CUSTOMER. 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

    THE REPORTED COMPLAINT WAS CONFIRMED. THE SERVICE REPAIR TECHNICIAN (SRT) REPLACED THE INVERTER BOARD. THE UNIT OPERATED TO MANUFACTURER'S SPECIFICATIONS. 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

    81 EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Additional Manufacturer Narrative · 1

    PER THE SERVICE ENGINEER FROM THE MANUFACTURER'S SUBSIDIARY, THE HEART LUNG MACHINE (HLM) WAS CHARGED TO FULLY MAXIMIZE THE BATTERY CAPACITY. AFTER MORE THAN 12 HOURS OF THE BATTERY CHARGING AND BEFORE THE END USER TURNED OFF THE UNIT, THEY NOTICED THAT THE DISPLAY ON THE CCM WAS ALREADY DIM. ON (B)(6) 2018 AFTER TURNING ON THE UNIT, THE END USERS NOTICED THAT THE CCM WAS DARK WITH NO BACKLIGHT ILLUMINATED. THE ROLLER PUMP CAN STILL BE CONTROLLED THROUGH THE CCM BUT IT NEEDS AN EXTERNAL LIGHT SOURCE TO SEE THE DISPLAY ON THE SCREEN.

    Description of Event or Problem · 1

    UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT THE DISPLAY ON THE CENTRAL CONTROL MONITOR (CCM) WAS DIM AND DARK. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57078 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 816300 00886799001325

    Patients

    Seq Age Sex Outcome Treatment
    1