BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4002400 · Received July 9, 2014

    Report

    Report Number
    1828100-2014-00578
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THIS COMPLAINT IS RELATED TO MDR 1828100-2014-00553 AND 1828100-2014-00594. THE FSR ORDERED A REPLACEMENT LEVEL MODULE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FIELD SERVICE REPRESENTATIVE (FSR) DURING TROUBLESHOOTING ON COMPLAINT MDR 1828100-2014-00553, THE LEVEL MODULE DID NOT RESPOND CORRECTLY. THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) HAD A SPARE LEVEL MODULE. THE FIELD SERVICE REPRESENTATIVE (FSR) INSTALLED THE LEVEL MODULE AND THE LEVEL SENSORS DID NOT RESPOND. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398901 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802111

    Patients

    Seq Age Sex Outcome Treatment
    1