BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON CARDIOLOGY HEMO

    MDR report key: 4616159 · Received March 16, 2015

    Report

    Report Number
    9616760-2015-00001
    Event Type
    Malfunction
    Date Received
    March 16, 2015
    Date of Event
    February 15, 2015
    Report Date
    May 1, 2016
    Manufacturer
    MCKESSON ISRAEL LTD.
    Product Code
    DQK
    PMA / PMN Number
    K131497
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON'S INITIAL INVESTIGATION DETERMINED THAT THE RT MONITOR SOFTWARE APPLICATION DETECTED THAT NO DATA WAS BEING RECEIVED FROM THE FRONT-END MONITORING COMPONENTS. WHEN THE RT MONITOR APPLICATION DETECTED THAT DATA WAS NOT BEING RECEIVED FROM THE FRONT-END COMPONENTS. WHEN THE RT MONITOR APPLICATION DETECTED THAT DATA WAS NOT BEING RECEIVED FROM THE FRONT-END COMPONENTS, IT AUTOMATICALLY ATTEMPTED TO RESTORE THE CONNECTION, AS DESIGNED. THE ROOT CAUSE OF THE CONNECTION FAILURE BETWEEN THE RT MONITOR AND THE FRONT-END IS CURRENTLY UNKNOWN, AND IS CURRENTLY UNDER INVESTIGATION. MCKESSON WILL FOLLOW UP WITH THE AGENCY WITH ANY NEW INFORMATION LEARNED AS A RESULT OF THE ONGOING INVESTIGATION.

    Additional Manufacturer Narrative · 1

    MCKESSON'S INITIAL INVESTIGATION DETERMINED THAT THE RT MONITOR SOFTWARE APPLICATION DETECTED THAT NO DATA WAS BEING RECEIVED FROM THE FRONT-END MONITORING HARDWARE COMPONENTS(PB1000). WHEN THE RT MONITOR APPLICATION DETECTED THAT DATA WAS NOT BEING RECEIVED FROM THE FRONT-END COMPONENTS, IT AUTOMATICALLY ATTEMPTED TO RESTORE THE CONNECTION, AS DESIGNED. ALL HARDWARE ITEMS AND CABLES FROM THE RT MONITOR TO THE PATIENT INTERFACE CABLES WERE REPLACED AT THE SITE ON APRIL 8TH, 2015 INCLUDING PB1000, CU, ECU AND RT MONITOR. AFTER EXTENSIVE INVESTIGATION, THE ROOT CAUSE OF THE ISSUE IS UNKNOWN, HOWEVER IT WAS MOST LIKELY CAUSED DUE TO CABLE DISCONNECTION. THIS IS CONSISTENT WITH THE BEHAVIOR OF THE PRODUCT, THE MANUFACTURER'S DOCUMENTATION AND OUR LOG FILES. NO RECURRENCE OF THIS INCIDENT WAS REPORTED SINCE THE HARDWARE HAS BEEN REPLACED.

    Description of Event or Problem · 1

    THE REPORTING FACILITY CONTACTED MCKESSON ON (B)(6) AND ALLEGED THAT THE RT MONITOR DISPLAYS IN THE PROCEDURE ROOM MOMENTARILY WENT BLANK AND THEN RETURNED TO A BLUE DESKTOP SCREEN DURING A STEMI CATHETERIZATION PROCEDURE PERFORMED ON (B)(6). THE DISPLAYS AUTOMATICALLY RESTORED AFTER SEVERAL SECONDS WITHOUT DISPLAYING INVASIVE BLOOD PRESSURE AND SHOWING AN INCORRECT HEART RATE VALUE OF 300 BPM. SHORTLY AFTER, THE HEART RATE STABILIZED TO THE EXPECTED CORRECT VALUE. THE INVASIVE BLOOD PRESSURE WAS UNAVAILABLE THROUGH THE REMAINDER OF THE PROCEDURE. THE CLINICAL STAFF TERMINATED THE PROCEDURE PRIOR TO ADDRESSING ALL LESIONS AS ORIGINALLY INTENDED BY THE PHYSICIAN. THERE WAS NO REPORT OF INJURY OR HARM TO THE PATIENT.

    Description of Event or Problem · 1

    THE REPORTING FACILITY CONTACTED MCKESSON ON FEBRUARY 16, AND ALLEGED THAT THE RT MONITOR DISPLAYS IN THE PROCEDURE ROOM MOMENTARILY WENT BLANK AND THEN RETURNED TO A BLUE DESKTOP SCREEN DURING A STEMI CATHETERIZATION PROCEDURE PERFORMED ON (B)(6). THE DISPLAYS AUTOMATICALLY RESTORED AFTER SEVERAL SECONDS WITHOUT DISPLAYING INVASIVE BLOOD PRESSURE AND SHOWING AN INCORRECT HEART RATE VALUE OF 300 BPM. SHORTLY AFTER, THE HEART RATE STABILIZED TO THE EXPECTED CORRECT VALUE. THE INVASIVE BLOOD PRESSURE WAS UNAVAILABLE THROUGH THE REMAINDER OF THE PROCEDURE. THE CLINICAL STAFF TERMINATED THE PROCEDURE PRIOR TO ADDRESSING ALL LESIONS AS ORIGINALLY INTENDED BY THE PHYSICIAN. THERE WAS NO REPORT OF INJURY OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177948 MCKESSON CARDIOLOGY HEMO MCKESSON CARDIOLOGY HEMO DQK MCKESSON ISRAEL LTD. 13.1

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other