BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 2100487 · Received May 13, 2011

    Report

    Report Number
    1828100-2011-01300
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 13, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE READINGS WERE INACCURATE AND DRIFTED. MIDWAY THROUGH THE CARDIOPULMONARY BYPASS, THE TEMPERATURE MEASUREMENT AND DISPLAY ON THE MONITOR WAS READING HIGHER THAN THE TEMPERATURE MEASURED BY THE ARTERIAL BLOOD TEMPERATURE PROBE OF THE OXYGENATOR. THE MONITOR DISPLAYED 40-42 DEGREES CELSIUS, WHEREAS THE OXYGENATOR TEMPERATURE PROBE WAS READING 35 DEGREES CELSIUS. THIS DISCREPANCY REMAINED THROUGHOUT THE CARDIOPULMONARY BYPASS. LIKEWISE, THE POTASSIUM MEASUREMENT ON THE MONITOR READ 8.0 AND THE ACTUAL POTASSIUM LEVEL (VIA ANALYZER) WAS 5.5. THE USER DID NOT TREAT THE VALUES OF THE MONITOR AND THEY REMAINED INACCURATE FOR THE REMAINDER OF THE CARDIOPULMONARY BYPASS. A STAT WHOLE BLOOD LAB ANALYZER WAS USED AS THEIR GUIDE TO MANAGE AND TREAT THE PT. THE USER REPORTED THAT THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO A PT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1