BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3871630 · Received April 16, 2014

    Report

    Report Number
    1828100-2014-00265
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) IS GOING TO TRY AND ORDER THE REPLACEMENT PARTS AND REPAIR THE UNIT HIMSELF. THIS PERFUSION SYSTEM WAS IN STORAGE AND HAS NOT BEEN USED IN AT LEAST THREE YEARS. THIS SYSTEM HAS BEEN SERVICED BY A THIRD PARTY FOR THE LAST THREE YEARS.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, FOUND THE PERFUSION SYSTEM BATTERIES WERE DEAD. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233443 TERUMO PERFUSION SYSTEM 8000 8K DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16422

    Patients

    Seq Age Sex Outcome Treatment
    1