BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 3842929 · Received March 13, 2014

    Report

    Report Number
    1828100-2014-00147
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 18, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THE USER PURCHASED THE DEVICE BETWEEN (B)(6) 2013 FROM THE SUBSIDIARY SITE. THE SUBSIDIARY'S MANUFACTURING ENGINEERING CENTER (MEC) DUPLICATED THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE MONITOR DOES NOT START. WHEN THE MONITOR WAS POWERED ON, IT ALARMED INTERMITTENTLY, A BURNT DOOR OCCURRED, AND THE DEVICE DID NOT START. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PATIENT/ PER CLINICAL REVIEW ON (B)(6) 2014: WHEN THE UNIT WAS POWERED ON DURING SET-UP, THERE WERE INTERMITTENT ALARMS AND A BURNT ODOR. THE UNIT WAS TURNED OFF QUICKLY AND NOT USED. A BACK-UP UNIT WAS USED FOR THE PROCEDURE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE DUE TO THIS EVENT. NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150416 TERUMO CDI 500 BLOOD PARAMETER MONITOR CDI 500 DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 500AVHCT

    Patients

    Seq Age Sex Outcome Treatment
    1