BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3842914 · Received March 13, 2014

    Report

    Report Number
    1828100-2014-00155
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 18, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) WILL DETERMINE IF BATTERIES NEED TO BE CHANGED OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE PERFUSION SYSTEM HAD ACCIDENTALLY BEEN LEFT ON OVERNIGHT AND UNPLUGGED. THE SYSTEM SHUT DOWN AND WHEN POWERED ON IN THE MORNING, THE FRONT PANEL BATTERY LIGHT WAS RED. AFTER THE SYSTEM HAD CHARGED FOR SEVERAL HOURS, THEY UNPLUGGED IT AND THE SYSTEM WENT DEAD. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150203 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1