BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4090038 · Received August 18, 2014

    Report

    Report Number
    1828100-2014-00672
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SWAPPED THE MODULE TO A DIFFERENT SLOT ON THE PERFUSION SYSTEM AND THAT DID NOT SOLVE THE ISSUE. THEY THEN REBOOTED THE SYSTEM. THEY THEN TOOK ANOTHER MODULE OFF ANOTHER SYSTEM AND THE PRESSURE MODULE FROM THE OTHER SYSTEM WORKED. THE SUSPECT MODULE WAS PUT ON ANOTHER SYSTEM BASE AND THE RED "X" CAME UP AGAIN WHEN THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) WAS TESTING THE UNIT AFTER THE CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE PRESSURE MODULE HAD A RED "X" OVER IT. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496291 TERUMO ADVANCED PERFUSION SYSTEM 1 AFS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802112

    Patients

    Seq Age Sex Outcome Treatment
    1