BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3060629 · Received April 5, 2013

    Report

    Report Number
    1828100-2013-00332
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 18, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM 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

    THE FIELD SERVICE REPRESENTATIVE (FSR) ADVISED THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) TO COMPLETELY DRAIN THE BATTERIES AND THEN CHARGE UP COMPLETELY TO TRY AND RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED AN ERROR MESSAGE "FULL BATTERY BACK-UP MAY NOT BE AVAILABLE". AFTER SURGERY, THE UNIT WAS TAKEN OUT OF SERVICE AT THE HOSPITAL. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141714 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 801763

    Patients

    Seq Age Sex Outcome Treatment
    1