BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 7436392 · Received April 17, 2018

    Report

    Report Number
    1828100-2018-00190
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    March 23, 2018
    Report Date
    October 10, 2018
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    PMA / PMN Number
    K163531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL TESTING WAS DONE BY A PRODUCT SURVEILLANCE TECHNICIAN (PST) TO CONFIRM THAT THE DISCONNECTION ACTUALLY CAUSED THE CENTRAL CONTROL MONITOR (CCM) NOT TO POWER UP. OBSERVED HARD DRIVE DISCONNECTED FROM ENHANCED INTEGRATED DRIVE ELECTRONICS (EIDE) PRINTED CIRCUIT BOARD (PCB). RECONNECTED HARD DRIVE TO EIDE PCB AND TESTED FOR ONE HOUR WITH NO ISSUES. 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 · 1

    (B)(4). PER THE FSR, THE ISSUE OCCURRED AFTER REPLACING THE HARD DRIVE AND LI COIN BATTERY. HE REPLACED THE CCM WITH A LOANER MONITOR. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATIONS. THE SUSPECT UNIT WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED. THE SERVICE REPAIR TECHNICIAN (SRT) OPENED THE CENTRAL CONTROL MONITOR (CCM) AND THE CONNECTIONS WERE CHECKED AND IT WAS FOUND THAT THE ENHANCED INTEGRATED DRIVE ELECTRONICS (EIDE) BOARD WAS NOT PLUGGED INTO THE HARD DRIVE. THE SRT REPLACED THE HARD DRIVE. THE UNIT OPERATED TO THE 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 · 1

    DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) DUPLICATED THE REPORTED COMPLAINT. HE OBSERVED THE CENTRAL CONTROL MONITOR (CCM) TO NOT POWER UP. THE REMOVAL AND REINSTALLATION OF THE SINGLE BOARD COMPUTER (SBC) BATTERY RESTORED THE POWER TO THE CCM. 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.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THE UNIT WOULD NOT POWER UP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281618 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 816300

    Patients

    Seq Age Sex Outcome Treatment
    1