BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 4574744 · Received March 2, 2015

    Report

    Report Number
    1828100-2015-00189
    Event Type
    Malfunction
    Date Received
    March 2, 2015
    Date of Event
    February 6, 2015
    Report Date
    August 13, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Removal / Correction Number
    1828100-08/07/15-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RELATED TO MDR #1828100-2015-00137, MDR 182810-2015-00152, AND MDR 1828100-2015-00199. REPORTED ISSUES OCCURRED WITH NEW SOFTWARE VERSION 1.69. PER THE CCP, HE NOTED THE UPPER LIMIT TO PERFORM AN IN-VIVO RECALIBRATION ON THE HCT VALUE. THIS USED TO BE 45, BUT IN THE NEW SOFTWARE IT IS 38. THE CCP FREQUENTLY RUNS PT HCT VALUES OF 45% ON SINGLE VENTRICLE AND OTHER CYANOTIC PTS BEFORE TERMINATING CARDIOPULMONARY BYPASS. THE CCP ALSO MENTIONED THAT THE HCT VALUES ARE NOT ACCURATE. AFTER PERFORMING A COUPLE OF IN VIVO RECALIBRATIONS, THE BPM WOULD READ 29% AND THE VALUE WILL COME BACK FROM THE LAB AT 25%. THIS IS TOO MUCH OF A DIFFERENCE FOR HIM. THEY DO PERFORM THE GAS CALIBRATIONS ON EACH SENSOR PRIOR TO THE CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE PERFUSIONIST NOTED THAT HE WAS NOT ABLE TO PERFORM HEMATOCRIT (HCT) IN-VIVO CALIBRATION FOR VALUES GREATER THAN THE OPERATING RANGE AND HCT VALUES ARE NOT ACCURATE ON THE BLOOD PARAMETER MONITOR (BPM). THE DEVICE WAS NOT CHANGED OUT, AS THEY CONTINUED TO USE THIS BPM. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PT. PER THE CLINICAL REVIEW ON (B)(6) 2015: WITH THE 1.69 SOFTWARE UPGRADE, THE OPERATING RANGE FOR HCT WAS CHANGED TO 17-38%. THIS WAS CHANGED TO MEET THE ACCURACY CLAIMS FOR HCT. THIS CTR DOES PEDIATRIC SURGERY AND AT TIMES THE HCT IS AT LEVELS OF UP TO 45% DUE TO PT CARDIAC PATHOLOGY AND/OR DUE TO HEMOCONCENTRATION DURING AND AFTER CPB. THIS USER IS STATING THE ACCURACY OF THE HEMATOCRIT HAS BEEN AFFECTED BY THE 1.69 UPGRADE AND HE HAS NOTICED THAT IN SOME CASES THE BPM WILL READ FOUR OR MORE HCT % UNITS HIGHER THAN THE LAB ANALYZED VALUE. THE UNIT IS BEING GAS CALIBRATED AND THE COLOR CHIP TEST IS PASSING DURING START UP. THE CASE WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY AND WITHOUT ASSOCIATED BLOOD LOSS. THERE WAS NO HARM OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142377 TERUMO CDI 500 BLOOD PARAMETER MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 500AHCT

    Patients

    Seq Age Sex Outcome Treatment
    1