BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3922162 · Received May 23, 2014

    Report

    Report Number
    1828100-2014-00434
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    May 2, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFTWARE DATA LOG WAS RETURNED TO THE MFR ON 05/02/2014 FOR FURTHER EVAL. THIS COMPLAINT IS RELATED TO THE FOLLOWING MDRS 1828100-2013-01150, 1828100-2014-00385, -00390, -00431, -00432, -00433, -00435 AND 00476.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THERE WAS A FAILURE NOTED IN THE TEMPERATURE MODULE ((B)(4)) OF THE PERFUSION SYSTEM PER END USER. THE DEVICE WAS NOT CHANGED OUT, AS THE USER REMOVED AND RECONNECTED TO THE NIC BOARD OR SHUT DOWN THE FULL SYSTEM AND REBOOTED A FEW MINUTES LATER FROM THE INITIAL BOOT-UP. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. 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
    309198 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEARAT LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802114

    Patients

    Seq Age Sex Outcome Treatment
    1