BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 2090167 · Received April 11, 2011

    Report

    Report Number
    1828100-2011-00883
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 4, 2011
    Report Date
    April 11, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE VENOUS SIDE READ LOW AND THAT THE VENOUS CABLE WAS FRAYED AT THE PROBE. THE DEVICE WAS NOT CHANGED OUT, AND THE PROCEDURE CONTINUED WITHOUT DELAY. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1