BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 3896790 · Received May 19, 2014

    Report

    Report Number
    1828100-2014-00367
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 25, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE POTASSIUM (K+) WAS CONSISTENTLY OFF BY TWO. EXACT DATE OF OCCURRENCE IS UNK. THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PT. PER CLINICAL REVIEW ON (B)(6) 2014: ACCORDING TO THE PERFUSIONIST (CCP), THE K+ VALUE DRIFTED UPWARD THE ENTIRE CASE. THE UNIT WAS GAS CALIBRATED PRIOR TO CPB AND IN THE EARLY MINUTES OF CPB, AN IN-VIVO CALIBRATION WAS COMPLETED. ON THE NEXT IN-VIVO RECALIBRATION, THE BLOOD PARAMETER MONITOR (BPM) K+ VALUE WILL BE ABOUT 2 MMOL/L HIGHER THAN THE LABORATORY ANALYZER. THE UNIT WILL BE ADJUSTED AND SLOWLY THE K+ VALUE WILL DRIFT HIGHER, IN SPITE OF NO K+ ADDITIONS TO THE PT AND/OR CPB CIRCUIT. ON NEXT LAB SAMPLE AND IN-VIVO RECALIBRATION, THE BPM WILL AGAIN HAVE A K+ VALUE ABOUT 2MMOL/L HIGHER THAN THE LABORATORY ANALYZER. THIS CONTINUES THROUGHOUT THE PROCEDURE. THIS HAS OCCURRED ON MULTIPLE OCCASIONS AND THE MONITOR OR SHUNT SENSOR WERE NOT CHANGED OUT DURING ANY SPECIFIC PROCEDURE. WITH THIS RECURRING, ACCORDING TO THE CCP, THE VALUES ARE KNOWN TO BE DRIFTING AND PT INTERVENTION IS NOT PERFORMED BASED SOLELY ON THE CDI VALUES. THE PROCEDURES WERE COMPLETED SUCCESSFULLY, WITHOUT DELAY AND WITHOUT ASSOCIATED BLOOD LOSS. THERE WAS NO HARM OBSERVED OR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297597 TERUMO CDI 500 BLOOD PARAMETER MONITOR CDI 500 DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 500AHCT

    Patients

    Seq Age Sex Outcome Treatment
    1 LABORATORY ANALYZER