BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2904075 · Received January 3, 2013

    Report

    Report Number
    1828100-2012-01644
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 1, 2012
    Report Date
    December 12, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA LOGS WERE SENT TO THE MFR FOR FURTHER EVAL. THE MANUFACTURING ENGINEERING CENTER (MEC) COULD NOT DUPLICATE THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE AIR ALARM SOUNDED WITH FLUID IN THE TUBING. AFTER A RESET OF THE UNIT, AN AIR ALARM SOUNDED AGAIN. THE CUSTOMER DID NOT USE A REPLACEMENT AIR SENSOR AS THEY WENT WITHOUT TO FINISH THE CASE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND 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
    3252 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 149673

    Patients

    Seq Age Sex Outcome Treatment
    1