BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3842918 · Received March 13, 2014

    Report

    Report Number
    1828100-2014-00188
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 17, 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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE FIELD SERVICE REPRESENTATIVE (FSR), THERE IS NO BATTERY BACKUP UNIT ON THIS CONTROL MODULE, AS IT IS PART OF A SYSTEM-1. THE LIGHTS ON THE CONTROL MODULE WERE NOT AFFECTED BY THE PROBLEM. THERE IS NO PROBLEM ATTACHING OR REMOVING THE PUMP HEAD, IT JUST VIBRATES A LITTLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CENTRIFUGAL DRIVE MOTOR HAD "EXCESSIVE VIBRATION" WHILE RUNNING AT CERTAIN SPEEDS. THE DEVICE WAS NOT CHANGED OUT, AS THE UNIT STILL FUNCTIONS AND WAS USED TO COMPLETE THE CASE. 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
    149731 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 164267

    Patients

    Seq Age Sex Outcome Treatment
    1