BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 3832570 · Received March 27, 2014

    Report

    Report Number
    1828100-2014-00235
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    January 31, 2014
    Report Date
    March 4, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THREE DAYS LATER ON (B)(6) 2014, THE BPM UNIT WAS USED WITH ANOTHER NEW SHUNT SENSOR IN A PROCEDURE. THERE WAS NO ANOMALY OBSERVED ON THE K+ VALUE OBTAINED FROM THE COMBINATION OF THE BPM UNIT AND THE SHUNT SENSOR. THE CUSTOMER IS NOT RETURNING THE UNIT AT THIS TIME. THEY ARE STILL USING THE BPM UNIT FOR CASES. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CUSTOMER ENCOUNTERED A LOW POTASSIUM (K+) VALUE WITH THE SHUNT SENSOR ON THE BLOOD PARAMETER MONITOR (BPM). THE SHUNT SENSOR WAS CHANGED OUT FOR A NEW ONE. HOWEVER, THE SITUATION DID NOT CHANGE. WITH THE COMBINATION OF THE NEW SHUNT SENSOR AND THE SAME BPM UNIT, A LOW K+ VALUE WAS OBTAINED AGAIN. THE CUSTOMER GAVE UP USING THE BPM UNIT THAT DAY. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THEY USED CEREBRAL OXIMETRY. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179542 TERUMO CDI 500 BLOOD PARAMETER MONITOR CDI 500 DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 500AVHCT

    Patients

    Seq Age Sex Outcome Treatment
    1 SHUNT SENSOR| CEREBRAL OXIMETRY