BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 2772261 · Received October 2, 2012

    Report

    Report Number
    1828100-2012-01241
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    August 25, 2012
    Report Date
    September 7, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE USER FACILITY'S BIOMEDICAL ENGINEER, THIS HAS BEEN AN ONGOING PROBLEM. HE WAS UNABLE TO QUANTIFY THE NUMBER OF TIMES THE REPORTED PROBLEM HAS HAPPENED. THE COMPLAINT COULD NOT BE DUPLICATED BY THE QUALITY LABORATORY TECHNICIAN. IF ADD'L INFO 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 THE BLOOD PARAMETER MONITOR (BPM) UNIT WAS STABLE, BUT THE VALUES WERE DRIFTING UP AND DOWN. THE DEVICE WAS NOT CHANGED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1