BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4110214 · Received September 10, 2014

    Report

    Report Number
    1828100-2014-00725
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED), HE STATED HE WAS NOT REPAIRING THE UNIT. HE REPLACED THE MODULE WITH ANOTHER ONE THEY HAD IN STOCK AND THE SUSPECT PRESSURE MODULE WAS DISPOSED OF. IF ADD'L INFO 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

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE SYSTEM-1 WAS ALERTING EVERY MINUTE AND THE PRESSURE POD WAS FLASHING RED. THEY TRIED PRESSURE MODULE ON ANOTHER MACHINE AND IT STILL DID NOT WORK. 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
    558995 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802112

    Patients

    Seq Age Sex Outcome Treatment
    1