BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 7109208 · Received December 12, 2017

    Report

    Report Number
    1828100-2017-00558
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 17, 2017
    Report Date
    February 2, 2018
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS PER SUBSIDIARY, THE CUSTOMER CONFIRMED THAT UPON BOOT UP, THE MONITOR DISPLAYED AN ERROR MESSAGE WHICH STATED, "DISK BOOT FAILURE, INSERT SYSTEM DISK AND PRESS ENTER". EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED COMPLAINT WAS CONFIRMED. DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) OBSERVED THE CENTRAL CONTROL MONITOR (CCM), TO BOOT WITH "DISK BOOT FAILURE, INSERT SYSTEM DISK AND PRESS ENTER" WHEN POWER WAS APPLIED. REPLACING THE SINGLE BOARD COMPUTER (SBC) RESTORED FUNCTIONALITY. SERVICE REPAIR TECHNICIAN (SRT) REPLACED THE SBC BOARD. 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) DID NOT BOOT UP WHEN TURNED ON. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890437 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