BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3901938 · Received May 28, 2014

    Report

    Report Number
    1828100-2014-00396
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 5, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. PER THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED), THE PERFUSIONISTS ARE USUALLY VERY GOOD ABOUT KEEPING THE CART PLUGGED IN SO THE BATTERIES HAVE A CHARGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THERE WAS NO BATTERY BACKUP ON THE PERFUSION SYSTEM. THE DEVICE WAS NOT CHANGED OUT, THEY RAN THE CASE WITHOUT BACKUP BATTERY. 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
    315073 TERUMO PERFUSION SYSTEM 8000 8K DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 16401

    Patients

    Seq Age Sex Outcome Treatment
    1