BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 6001090 · Received October 5, 2016

    Report

    Report Number
    1828100-2016-00660
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 12, 2016
    Report Date
    December 15, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THE BIOMEDICAL TECHNICIAN ORDER A REPLACEMENT EPGS AND RETURNED THE SUSPECT DEVICE TO THE MANUFACTURER FOR FURTHER EVALUATION. DURING LABORATORY EVALUATION, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) NOTED THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) DID NOT POWER ON BECAUSE OF A DEFECTIVE GENERIC BOARD, PART NUMBER: 801514, SERIAL NUMBER: (B)(4).THE EPGS WAS CONNECTED TO A SYSTEM ONE SIMULATOR AND CENTRAL CONTROL MONITOR (CCM), THE FRONT INDICATOR LIGHT OF THE EPGS DID NOT ILLUMINATE AND THE EPGS DID NOT SHOW UP ON CCM SCREEN. THE PST TEMPORARILY REPLACED THE GENERIC BOARD WITH A LAB USE ONLY GENERIC BOARD AND THE EPGS THEN OPERATED AS DESIGNED. VISUAL INSPECTION OF THE SUSPECT GENERIC BOARD DID NOT FIND ANY ANOMALIES. THE UNIT WILL BE SENT TO SERVICE TO BE BROUGHT TO MANUFACTURER'S SPECIFICATION PRIOR TO BEING RELEASED FOR CLINICAL USE. 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

    THE REPORTED COMPLAINT WAS CONFIRMED. THE SERVICE REPAIR TECHNICIAN (SRT) REPLACED THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) POD ASSEMBLY. THE NEWLY INSTALLED UNIT OPERATED WITH 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.

    Description of Event or Problem · 1

    THE BIOMEDICAL TECHNICIAN (BMET) REPORTED THAT DURING A TWO-YEAR PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) THAT WAS TO REPLACE THE EXISTING EPGS, HAD NO LIGHTS, NO POWER, AND DID NOT SHOW UP ON CENTRAL CONTROL MONITOR (CCM) SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE REPORTED COMPLAINT OCCURRED DURING FIELD SERVICE INSTALLATION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651026 TERUMO ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801188

    Patients

    Seq Age Sex Outcome Treatment
    1