BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1083350 · Received July 28, 2008

    Report

    Report Number
    1828100-2008-00379
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    May 28, 2007
    Report Date
    July 28, 2008
    Manufacturer
    TERUMP CARDIOVASCUALR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS ORIGINALLY REPORTED IN COMBINATION WITH ANOTHER EVENT ON MEDICAL DEVICE REPORT NUMBER 1828100-2008-00307. DURING THE EVALUATION OF THE DEVICE, IT WAS DETERMINED AN ADDITIONAL REPORT SHOULD BE SUBMITTED.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CENTRIFUGAL PUMP CONTROL MODULE DID NOT DISPLAY FLOW VALUES AS EXPECTED. TECHNICAL SUPPORT INSTRUCTED THE USER TO PLACE THE MODULE INTO ANOTHER CHANNEL ON THE POWER SUPPLY. THE USER STATED THAT MOVING THE MODULE REMEDIED THE PROBLEM. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO A PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 CENTRIFUGAL PUMP CONTROL MODULE DTQ TERUMP CARDIOVASCUALR SYSTEMS CORP 801046

    Patients

    Seq Age Sex Outcome Treatment
    1