BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3832582 · Received March 27, 2014

    Report

    Report Number
    1828100-2014-00239
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THIS COMPLAINT IS RELATED TO MDR # 1828100-2014-00205. PER THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED), THERE WAS 24 VOLTS FROM THE PERFUSION SYSTEM TO THE OCCLUDE. HE CHECKED OUT THE MEMBRANE SWITCH AND MEASURE OF RESISTANCE (OHMS) CHECKED OUT CORRECTLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE VENOUS OCCLUDER WOULD NOT OPERATE. AS A RESULT, AN ALTERNATE DEICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179544 TERUMO PERFUSION SYSTEM 8000 8K DTQ TERUMO CARDIOVASCULAR SYSTEM 16418

    Patients

    Seq Age Sex Outcome Treatment
    1