BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4741912 · Received April 29, 2015

    Report

    Report Number
    1828100-2015-00316
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 7, 2015
    Report Date
    August 11, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Removal / Correction Number
    1828100-10/14/11-020-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBSIDIARY SITE DETERMINED THE SINGLE BOARD COMPUTER (SBC) NEEDS REPLACED.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED. THE MANUFACTURER'S SUBSIDIARY INVESTIGATED THE ISSUE AND ISOLATED THE CAUSE OF THE COMPLAINT EFFECTS TO THE SINGLE BOARD COMPUTER (SBC). WHEN THEY INSTALLED A NEW SBC, THEY REPORTED THE CENTRAL CONTROL MONITOR (CCM) OPERATED AS INTENDED. THROUGH CORRESPONDENCE WITH THE MANUFACTURING ENGINEERING CENTER (MEC), THEY DID NOT REPORT ANY DAMAGE TO THE SBC BOARD. NO ADDITIONAL ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THERE WAS AN ERROR MESSAGE OF "DISK BOOT FAILURE, INSERT SYSTEM DISK AND PRESS ENTER" DISPLAYED ON THE CENTRAL CONTROL MONITOR (CCM). THEY TURNED OFF THE SYSTEM-1, AND THE CCM DOES NOT DISPLAY. THE DEVICE WAS NOT CHANGED OUT, AS THE CASE WAS POSTPONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280894 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (CCM) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816300

    Patients

    Seq Age Sex Outcome Treatment
    1