BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON CARDIOLOGY HEMO

    MDR report key: 4046963 · Received August 26, 2014

    Report

    Report Number
    9616760-2014-00002
    Event Type
    Malfunction
    Date Received
    August 26, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MCKESSON ISRAEL LTD.
    Product Code
    DQK
    PMA / PMN Number
    K131497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MCKESSON INVESTIGATION REVEALED THAT IN SPECIFIC CONFIGURATIONS WHERE THE USER CLICKS THE 'APPLY LOCAL CONFIGURATIONS FOR THIS SCREEN TO ALL STATIONS' OR 'APPLY TO ALL STATIONS' BUTTONS, INCORRECT HEMOGLOBIN VALUE MAY BE UTILIZED BY THE DEVICE TO CALCULATE THE FOLLOWING CLINICAL PARAMETERS: O2 CONTENT AND O2 CAPACITY; FICK CO, STROKE VOLUME AND STROKE WORK; VALVE AREA AND FLOW; QP, QS, QE FLOWS, SHUNT CALCULATIONS AND SHUNT RATIO; VASCULAR RESISTANCE; REGURGITATION FRACTION. THE CONSEQUENCES OF THE INCORRECT CALCULATIONS MAY POTENTIALLY LEAD TO DELAY IN APPROPRIATE TREATMENT OR INCORRECT TREATMENT. MCKESSON WILL DISTRIBUTE A FIELD SAFETY NOTICE TO ALL AFFECTED CUSTOMERS TO PROVIDE INSTRUCTIONS FOR AN IMMEDIATE CORRECTION THAT WILL PREVENT THIS ISSUE FROM OCCURRING. MCKESSON WILL INFORM AFFECTED CUSTOMERS OF THE POTENTIAL IMPACT OF THIS ISSUE TO PRIOR PROCEDURES, AND WILL PROVIDE A SOFTWARE UPDATE TO ALL AFFECTED CUSTOMERS TO PREVENT FUTURE RECURRENCE OF THIS ISSUE. TO DATE, MCKESSON IS NOT AWARE OF ANY HARM TO PATIENTS.

    Description of Event or Problem · 1

    THE REPORTING FACILITY ALLEGED THAT THE HEMOGLOBIN VALUE DISPLAYED IN ONE OF THE (B)(4) CARDIOLOGY HEMO APPLICATION SCREENS WAS NOT CORRECTLY CONVERTED IN CALCULATED RESULTS WHICH ARE USED TO SUPPORT IN THE TREATMENT DECISION FOR CARDIAC PATIENTS. THE REPORTING FACILITY REVIEWED AFFECTED PATIENT RECORDS AND DETERMINED THAT NO CHANGES TO TREATMENT DECISIONS WERE REQUIRED. NO HARM TO PATENTS HAS BEEN REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518067 MCKESSON CARDIOLOGY HEMO MCKESSON CARDIOLOGY HEMO DQK MCKESSON ISRAEL LTD. 13.0HF3

    Patients

    Seq Age Sex Outcome Treatment
    1