BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 6124249 · Received November 23, 2016

    Report

    Report Number
    1828100-2016-00761
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    November 1, 2016
    Report Date
    December 27, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K131041
    Removal / Correction Number
    1828100-06/05/2007-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FSR CHANGED THE CCM OUT AND PERFORMED THE NFC ON THE HEART LUNG MACHINE. THE SUSPECT CCM WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Additional Manufacturer Narrative · 1

    DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) OBSERVED A "SYSTEM BATTERY IS DEAD - REPLACE AND RUN SETUP. REAL TIME CLOCK ERROR" DURING BOOT SEQUENCE, CONFIRMING THE REPORTED COMPLAINT. THE CENTRAL CONTROL MONITOR (CCM) WAS POWERED ON AND ATTEMPT TO BOOT-UP, BOOT SEQUENCE DISCONTINUES AND DISPLAYED ERROR STATEMENTS OF SYSTEM BATTERY IS DEAD- REPLACE AND RUN SETUP AND REAL TIME CLOCK ERROR. CCM WAS REBOOTED AGAIN FIVE TIMES AND NOTED THE SAME ERROR. THE UNIT WAS POWERED OFF AND THE BACK COVER WAS REMOVED. REAL TIME CLOCK (DALLAS CHIP) WAS REMOVED AND INSTALLED LAB USE ONLY (LUO) REAL TIME (DALLAS CHIP) AND POWERED ON. THE CCM WAS OBSERVED TO COMPLETE THE BOOT PROCESS. THE UNIT FUNCTIONALITY WAS TESTED BY OPENING VARIOUS OF PERFUSION SCREENS AND OBSERVED NO ISSUE. THE PRODUCT WILL BE SENT TO SERVICE TO BE BROUGHT TO MANUFACTURERS 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 NFC (NOTICE OF FIELD CORRECTION), THE BATTERY ON THE MOTHER BOARD OF THE CENTRAL CONTROL MONITOR (CCM) WAS DEAD. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775009 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP. 802100

    Patients

    Seq Age Sex Outcome Treatment
    1