BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON CARDIOLOGY HEMO

    MDR report key: 4012736 · Received July 10, 2014

    Report

    Report Number
    9616760-2014-00001
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    January 19, 2014
    Report Date
    January 19, 2014
    Manufacturer
    MCKESSON ISRAEL LTD.
    Product Code
    MWI
    PMA / PMN Number
    K131497
    Removal / Correction Number
    9616760-06-25-2014-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING DEFICIENCY WAS IDENTIFIED INTERNALLY BY MCKESSON PERSONNEL DURING A LABELING REVIEW. MCKESSON CARDIOLOGY HEMO INCORPORATED THE FDA CLEARED ARGUS PB VITAL SIGNS MONITORING DEVICE ((B)(4)), MANUFACTURED BY SCHILLER (B)(4), WHICH PROVIDES PATIENT MONITORING CAPABILITIES AND ACQUIRES, ANALYZE AND DISPLAYS PATIENT VITAL SIGNS AND OTHER PERTINENT CLINICAL DATA. THE ARGUS PB DEVICE MUST UNDERGO RECOMMENDED ANNUAL MAINTENANCE TESTING TO VERIFY PROPER FUNCTIONING AND CALIBRATION. IF THE DEVICE IS NOT WITHIN CALIBRATION SPECIFICATIONS, THE MCKESSON CARDIOLOGY HEMO SYSTEM MAY NOT FUNCTION PROPERLY AND WHICH POTENTIALLY MAY AFFECT THE ACCURACY OF DISPLAYED CLINICAL PARAMETERS. ON (B)(4) 2014 MCKESSON INITIATED A CORRECTION TO THE MCKESSON CARDIOLOGY HEMO INSTRUCTIONS FOR USE OF THE AFFECTED CUSTOMERS VIA A FIELD SAFETY NOTICE (#PRU-10001) FOR CLARIFICATION AND REMINDER OF THE REQUIREMENTS, AND IF NEEDED, TO PERFORM AN ANNUAL MAINTENANCE TEST OF THE MCKESSON CARDIOLOGY HEMO. ANNUAL MAINTENANCE TESTING CAN BE PERFORMED BY EITHER A MCKESSON FIELD ENGINEER OR BY STAFF MEMBERS AT THE CLINICAL FACILITY WHO HAVE BEEN CERTIFIED BY MCKESSON. IF THE TESTING REVEALS THAT ONE OR MORE OF THE CLINICAL PARAMETERS FAIL THE MAINTENANCE TESTING, THE UNIT WILL BE REPLACED.

    Description of Event or Problem · 1

    MCKESSON HAS IDENTIFIED THAT THE NEED FOR PERFORMING ANNUAL MAINTENANCE TESTING IS NOT REITERATED IN THE MCKESSON CARDIOLOGY HEMO INSTRUCTIONS FOR USE WITH VERSIONS 12.2 AND EARLIER, ALTHOUGH EACH UNIT HAS AN ATTACHED STICKER INDICATING THE DUE DATE OF THE NEXT MAINTENANCE TEST REQUIRED, AND AS COMMUNICATED TO THE CUSTOMERS AS PART OF THE USER ADMINISTRATOR TRAINING. TO DATE, THERE HAVE NO REPORTS OF AN ADVERSE EVENT, INJURY OR ILLNESS AS A RESULT OF THE LABELING DEFICIENCY DESCRIBED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404639 MCKESSON CARDIOLOGY HEMO MCKESSON CARDIOLOGY HEMO MWI MCKESSON ISRAEL LTD. SW VER. 12.2 HF4

    Patients

    Seq Age Sex Outcome Treatment
    1