BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4030153 · Received July 31, 2014

    Report

    Report Number
    1828100-2014-00617
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THIS COMPLAINT IS RELATED TO MDR #1828100-2014-00614, 1828100-2014-00618, 1828100-2014-00619. THE CUSTOMER EXPERIENCED A DIFFERENT ISSUE ON INITIAL START-UP OF FOUR SEPARATE SYSTEMS ALL ON THE SAME DAY, AND AROUND THE SAME TIME. PER THE SUBSIDIARY SITE, THE CUSTOMER TURNED ON THE SYSTEM WITH BATTERY MODE. THEREFORE, IT WAS NOT LIKELY THAT THE NOISE FROM WALL OUTLET CAUSED THIS COMPLAINT. SOFTWARE DATA LOGS WERE REC'D BY THE MANUFACTURER ON (B)(4) 2014 FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, WHEN THE CUSTOMER BOOTED UP THE SYSTEM-1, "SMALL ROLLER PUMP: 2 FAIL" ERROR WAS DISPLAYED ON THE HOME SCREEN OF CENTRAL CONTROL MONITOR (CCM). THE DEVICE WAS NOT CHANGED OUT, AS THE CUSTOMER REBOOTED THE SYSTEM AND THE MESSAGE WAS GONE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448969 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (ROLLER PUMP) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801040

    Patients

    Seq Age Sex Outcome Treatment
    1