BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 3070262 · Received April 16, 2013

    Report

    Report Number
    1828100-2013-00356
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 26, 2013
    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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE (CPB), THE BLOOD PARAMETER MONITOR (BPM) WOULD READ UP TO 12% VENOUS OXYGEN SATURATION VALUE HIGHER BEFORE CALIBRATION. THIS WAS NOT SEEN WITH THE SECOND DEVICE NOR WITH LOANER. THE DEVICE WAS NOT CHANGED OUT, AS THE BPM WAS CALIBRATED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT. PER THE CLINICAL REVIEW: PER THE PERFUSIONIST, (CCP), THE INACCURACY ISSUE WAS NOT WITH THE VENOUS OXYGEN SATURATION MEASUREMENT (AS WAS THE INITIAL UNDERSTANDING OF THE REPORT), BUT WAS WITH THE HEMATOCRIT MEASUREMENT. ACCORDING TO THE CCP, PRIOR TO THE IN-VIVO RECALIBRATION DURING THE FIRST MINUTES OF CPB, THE BPM HEMATOCRIT MEASUREMENT COULD BE 12 PERCENT POINTS DIFFERENT THAN THEIR LABORATORY ANALYZER. THEY DO NOT PERFORM ANY CLINICAL MANEUVERS UNTIL THE IN-VIVO RECALIBRATION IS COMPLETED. AFTER THE IN-VIVO IS COMPLETED, THE HEMATOCRIT IS USUALLY JUST 1-2 PERCENT UNITS DIFFERENCE FROM THE LABORATORY ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163234 TERUMO CDI 500 BLOOD PARAMETER MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 500AHCT

    Patients

    Seq Age Sex Outcome Treatment
    1