BEUDAMED
    FDA Adverse Event Death Summary report: N

    CHANGE HEALTHCARE CARDIOLOGY HEMO

    MDR report key: 24010403 · Received January 8, 2026

    Report

    Report Number
    8022570-2026-00001
    Event Type
    Death
    Date Received
    January 8, 2026
    Date of Event
    November 20, 2025
    Report Date
    January 9, 2026
    Manufacturer
    CHANGE HEALTHCARE CANADA COMPANY
    Product Code
    MWI
    UDI-DI
    17540262100105
    PMA / PMN Number
    K131497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SEE SECTION B5.

    Description of Event or Problem · 0

    CHANGE HEALTHCARE (CHC) IS FILING THIS REPORT BECAUSE A PATIENT DEATH OCCURRED AT A CUSTOMER FACILITY; CHC'S INVESTIGATION, CONSISTENT WITH THE TREATING CLINICIAN'S ACCOUNT, DETERMINED THAT THE CHC CARDIOLOGY HEMO SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT. EVENT SUMMARY: ON DEC 10TH 2025, DURING A SALES CALL WITH A U.S. CUSTOMER (B)(6), IT WAS REVEALED THAT AN ADVERSE EVENT OCCURRED ON (B)(6) WHILE THE HEMO SYSTEM WAS NOT RESPONDING. AT THE REQUEST OF CHC, THE CUSTOMER PROVIDED ADDITIONAL DETAILS AND THEIR INTERPRETATION OF THE CASE. THE PATIENT WAS A 75-YEAR-OLD WITH SEVERE CARDIAC HISTORY AND ARRIVED AT THE CUSTOMER FACILITY FOR A CORONARY INTERVENTION PROCEDURE. UPON ARRIVAL, THE PATIENT'S CONDITION DETERIORATED RAPIDLY. AN EMERGENCY HEART ATTACK WAS ACTIVATED; THE PATIENT WAS INTUBATED AND WAS ACTIVELY BEING RESUSCITATED. THE CUSTOMER INDICATED THAT THE PATIENT INFORMATION WAS NOT TRANSFERRING TO THE REAL TIME (RT) MONITOR, AND FOR APPROXIMATELY 40 MINUTES, VITAL SIGNS AND CARDIAC RHYTHM WERE UNAVAILABLE ON THE RT MONITOR. CHANGE HEALTHCARE CUSTOMER SUPPORT WAS CONTACTED, AND THE CHC REPRESENTATIVE WALKED THE CUSTOMER THROUGH REMOVING A FIREWALL THAT WAS DISRUPTING COMMUNICATION BETWEEN SYSTEM COMPONENTS. ONCE THESE FIREWALLS WERE REMOVED, THE SYSTEM WAS OPERATIONAL. THE CUSTOMER DID NOT INDICATE TO CHC AT THAT TIME THAT AN ADVERSE EVENT HAD OCCURRED. DESPITE RESUSCITATIVE EFFORTS, THE PATIENT ULTIMATELY PASSED AWAY IN THE CATH LAB. INVESTIGATION SUMMARY: IT WAS DETERMINED THAT THE COMMUNICATION BETWEEN THE INFOSYSTEM AND RT MONITOR WAS DISRUPTED AFTER AN IT SYSTEM UPGRADE WAS PERFORMED BY THE HOSPITAL IT DEPARTMENT, THE NIGHT BEFORE THE PATIENT'S ARRIVAL. INVESTIGATION SUGGESTS THAT FIREWALL CHANGES DISRUPTED COMMUNICATION BETWEEN SYSTEM COMPONENTS, PREVENTING SUCCESSFUL LAUNCH OF THE HEMO INFOSYSTEM. CHANGE HEALTHCARE DOES NOT CONFIGURE OR MANAGE FIREWALLS; THESE ARE CONTROLLED BY THE HOSPITAL IT TEAM. THE PRODUCT LABELING INCLUDES INSTRUCTIONS FOR CORRECT FIREWALL CONFIGURATIONS TO ENSURE PROPER SYSTEM OPERATION, AND THESE WERE NOT FOLLOWED BY THE CUSTOMER. UPON FURTHER INVESTIGATION INTO THE SYSTEM LOGS, FULL DISCLOSURE DOCUMENTS AND CONVERSATIONS WITH THE CUSTOMER, IT WAS CONCLUDED THAT BASIC VITAL SIGNS (ECG, IBP) WERE AVAILABLE ON THE RT MONITOR. ECG TRACING APPEARED ON THE RT MONITOR THROUGHOUT THE PROCEDURE. THE IBP SIGNAL WAS AVAILABLE AT THE START OF THE PROCEDURE AND DISAPPEARED FOR 40 MINUTES UNTIL 1 MINUTE AFTER FIREWALL WERE REMOVED. A "CABLE OFF" ERROR MESSAGE APPEARED DURING THIS TIME. DUE TO THIS BEHAVIOR, AND THE FACT THAT THE IBP SIGNAL WAS AVAILABLE AT THE START OF THE PROCEDURE, IT IS UNLIKELY THAT THE CAUSE OF THE SIGNAL DISAPPEARANCE WAS A RESULT OF THE FIREWALL. A REVIEW OF THE FRONT-END UNIT LOGS AND ERRORS FURTHER CONFIRMS THAT THE MISSING IBP WAVEFORMS WERE A RESULT OF THE IBP CABLE BEING DISCONNECTED DURING THIS TIME. THIS ALIGNS WITH THE KNOWN ERRORS SPECIFICATIONS OF THE FRONT-END UNIT AND THE SYSTEM BEHAVIOR WHEN A CABLE IS DISCONNECTED. BASED ON THESE FINDINGS AND THE CLINICIAN'S STATEMENT, AVAILABLE EVIDENCE INDICATES THAT THE CHC CARDIOLOGY HEMO SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH; THIS REPORT IS SUBMITTED SOLELY DUE TO THE OCCURRENCE OF THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71992 CHANGE HEALTHCARE CARDIOLOGY HEMO MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS), PRODUC MWI CHANGE HEALTHCARE CANADA COMPANY 15.0.1 17540262100105

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Death