BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 3912723 · Received May 14, 2014

    Report

    Report Number
    1828100-2014-00350
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PATIENT. PER THE CLINICAL REVIEW ON (B)(6) 2014: THIS CENTER HAS HAD SIMILAR ISSUES DURING ECMO. THIS COMPLAINT IS BASED ON THE BLOOD PARAMETER MONITOR (BPM) USED FOR ROUTINE CARDIAC SURGERY AND THEY HAVE HAD ISSUES BOTH DURING SET-UP AND DURING CARDIOPULMONARY BYPASS. ACCORDING TO PERFUSIONIST (CCP), THE POTASSIUM (K+) DRIFTING ISSUE IS WORSE SINCE THE "POTTING NFC" WAS COMPLETED. THE ISSUE IS BOTH A SENSITIVITY ERROR WITH K+ AND A DRIFTING UPWARDS OF K+ LEVELS DURING CPB, IN SPITE OF ACTUAL K+ LEVELS BEING CONSTANT OR DROPPING. AT TIMES, THEY GET A SENSITIVITY ERROR DURING START-UP AND AT TIMES THEY GET THIS SAME ERROR MESSAGE WHEN AN IN-VIVO CALIBRATION IS ATTEMPTED DURING CPB. OTHER TIMES, THEY DON'T GET A SENSITIVITY ERROR FOR K+, BUT THE K+ LEVEL DRIFTS UPWARD DURING THE PROCEDURE AND WHEN COMPARED TO THE LAB ANALYZER, THE K+ LEVEL IS MUCH LOWER THAN THE BPM MEASURE. THE CCP STATED THIS IS KNOWN BY THE USER AND THEY DO NOT TREAT THE PATIENT BASED ON THE K+ LEVEL OF THE BPM. THE CCP ALSO STATED, THE OTHER SHUNT SENSOR PARAMETERS ARE VERY CLOSE IN MEASUREMENT TO THE LAB ANALYZER. WHEN THEY EXPERIENCE A K+ SENSITIVITY ERROR, THEY WILL SOMETIMES CHANGE THE SHUNT SENSOR AND SOMETIMES USE ANOTHER MONITOR, BUT THERE IS NO CONSISTENT FIX FOR THE ISSUE. FOR K+ DRIFT, THEY JUST CONTINUE TO USE THE SYSTEM AND DO MORE FREQUENT BLOOD SAMPLES TO KEEP CLOSER TABS ON THE K+ LEVEL. THE PROCEDURES ARE COMPLETED SUCCESSFULLY, WITHOUT DELAY. THEY DO, AT TIMES, DRAW MORE LAB SAMPLES BUT THESE SAMPLES NEED VERY SMALL VOLUMES OF BLOOD AND THE CCP DOES NOT THINK OF THESE AS ADDITIONAL BLOOD LOSS. THERE HAS BEEN NO PATIENT HARM OBSERVED OR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288093 TERUMO CDI 500 BLOOD PARAMETER MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 500AHCT

    Patients

    Seq Age Sex Outcome Treatment
    1 LABORATORY ANALYZER