BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 9000

    MDR report key: 4241253 · Received September 4, 2014

    Report

    Report Number
    1828100-2014-00737
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 14, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K871131
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SUPPORT ADVISED THE CUSTOMER ON THIS ISSUE: YOU CAN FIRST CHECK BY VERIFYING THE JUMPER IS STILL INSTALLED AT J3 ON THE CENTRAL PROCESSING UNIT (CPU) BOARD IN THE FRONT TRAY OF THE PERFUSION SYSTEM CHASSIS. IF THAT IS ON CORRECTLY, OPEN UP THE 9K MONITOR AND CHECK ALL THE CABLE CONNECTIONS TO SEE IF THEY SEATED PROPERLY. IF THIS DOESN'T WORK MAYBE GET ANOTHER MONITOR IF AVAILABLE, AS THE OLDER 9K MONITORS WILL WORK ON THIS 9K PERFUSION SYSTEM. PER THE SUBSIDIARY ASSOCIATE, DURING TECHNICAL TROUBLESHOOTING, THE CPU/MEMORY BOARD HAS BEEN REPAIRED. THE HOSPITAL HAS REPLACED THE MEMORY RANDOM ACCESS MEMORY (RAM), ERASABLE ELECTRONICALLY PROGRAMMABLE READ ONLY MEMORY (EEPROM) AND BATTERY ON THE BOARD. THESE PARTS WERE TAKEN FROM A SPARE SYSTEM. THE PERFUSION SYSTEM IS NOW WORKING PROPERLY. 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 USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE MEDICAL CENTER, THE PERFUSION SYSTEM SCREEN WAS STUCK IN A REBOOT LOOP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542836 TERUMO PERFUSION SYSTEM 9000 9K DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 164290

    Patients

    Seq Age Sex Outcome Treatment
    1