BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 4093167 · Received August 21, 2014

    Report

    Report Number
    1828100-2014-00686
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 30, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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, THE POTASSIUM (K+) READING VARIED A LOT ON THE BLOOD PARAMETER MONITOR (BPM) IN REFERENCE TO ANOTHER ANALYZER THEY HAVE IN THE OPERATING ROOM. THE BPM READS 2.1 AND THE EXTERNAL ANALYZER READS 5.5. 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: THE DESCRIBED ISSUE IS THE K+ MEASURE ON THE BPM WAS SIGNIFICANTLY LOWER THAN THE MEASUREMENT OF THE BLOOD GAS ANALYZER. ACCORDING TO THE SUBSIDIARY SITE, ONLY THE POTASSIUM MEASURE WA SNOT ACCURATE IN COMPARISON TO THE LAB DEVICE. THE USER DID NOT ENTER THE K+ CODE DURING PREPARATION FOR GAS CALIBRATION (USING THE 540 CALIBRATOR) AND THE GAS CALIBRATION WAS DONE AND SUCCESSFUL. THE INACCURACY WAS FIRST NOTICED AFTER THE INITIAL IN-VIVO CALIBRATION. THERE WERE NO ERROR CODES DISPLAYED. NOTHING WAS CHANGED OUT, AND THE BPM CONTINUED TO BE USED FOR THE PROCEDURE, AS THE OTHER PARAMETERS WERE ACCURATE. IT WAS OBVIOUS TO THE USER THAT THE K+ WAS NOT ACCURATE AND NO PATIENT TREATMENT WAS PERFORMED BASED SOLELY ON THE K+ VALUES. THE PROCEDURE WAS 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
    506875 TERUMO CDI 500 BLOOD PARAMETER MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 500AVHCT

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTERNAL GAS ANALYZER