BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 3042338 · Received April 4, 2013

    Report

    Report Number
    1828100-2013-00324
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 15, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE PERFUSIONIST WAS HAVING TROUBLE WITH THE HEMATOCRIT SATURATION (H/SAT) NUMBER WAS JUMPING AROUND. THE INACCURACIES WERE NOTED ON THREE SEPARATE OCCASIONS. THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT. PER THE CLINICAL REVIEW: DURING START-UP, H/S MODULE COLOR CHIP FAILURE MESSAGE WAS DISPLAYED. THE H/S PROBE MOUNTING ON THE SIDE OF THE MONITOR WAS CHECKED AND THE COLOR CHIP TEST WAS RETRIED. A SECOND FAILURE WAS EXPERIENCED AND THE CLINICAL TEAM CLEANED THE SURFACE OF THE COLOR CHIP AND THE H/S PROBE WINDOW AND AGAIN RETRIED THE TEST. THEY EXPERIENCED A THIRD FAILURE AND AGAIN CHECKED THE MOUNTING OF THE PROBE AND RE-CLEANED THE SURFACES. AFTER THESE STEPS, THE COLOR CHIP TEST PASSED AND THEY WERE ABLE TO USE THE MONITOR FOR THE PROCEDURE. SHORTLY AFTER GOING ON CPB, THE PERFUSIONIST RAN AN IN-VIVO RECALIBRATION BY COMPARING THE RESULTS OF THE BLOOD PARAMETER MONITOR (BPM) TO AN INDEPENDENT LAB ANALYZER. IT WAS DISCOVERED THAT THE BPMS HEMATOCRIT MEASUREMENT WAS 4% UNITS HIGHER THAN THE LAB ANALYZER. AFTER THE IN-VIVO RECALIBRATION WAS COMPLETED, THE HEMATOCRIT MEASUREMENTS OF THE BPM CLOSELY TRACKED THE LAB ANALYZER. THERE WERE NO INCORRECT OR MISSED TREATMENTS BASED ON THE INITIAL INACCURATE HEMATOCRIT VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138294 TERUMO CDI 500 BLOOD PARAMETER MONITOR DRY TERUMO CARDIOVASCULAR SYSTEM CORP 500AHCT

    Patients

    Seq Age Sex Outcome Treatment
    1