BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 4122506 · Received September 22, 2014

    Report

    Report Number
    1828100-2014-00812
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Report Date
    August 29, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) DURING TROUBLESHOOTING OF PARENT COMPLAINT MDR #1828100-2014-00722, THE CARDIOPLEGIA PUMP WOULD NOT RUN. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587514 TERUMO TCM II COOLING AND HEATING SYSTEM TERUMO TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 4415

    Patients

    Seq Age Sex Outcome Treatment
    1