BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY ACUTE CARE SYSTEM (M540)

    MDR report key: 7131422 · Received December 19, 2017

    Report

    Report Number
    1220063-2017-00066
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    December 14, 2017
    Report Date
    January 30, 2018
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K113798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT WAS RECEIVED REGARDING NO ARTERIAL PRESSURE ALARM. THE ISSUE COULD BE CONFIRMED FROM THE LOG FILES. IT WAS FOUND THAT THE ALARMS WERE SUPPRESSED AFTER THE IBP PRESSURE WAS ZEROED AND IT DID NOT RE-ARM AFTER 30 SECONDS WHEN IT SHOULD HAVE. ROOT CAUSE WAS IDENTIFIED AS A SOFTWARE ISSUE WHICH HAPPENS DURING A RACE CONDITION. THIS OCCURS IF THE M540 IS PUT INTO STANDBY AND THE HEMO POD IS THEN CONNECTED. IF THE IBP PRESSURE IS ZEROED AFTER THIS WORKFLOW, THE 30 SECOND TIMER NEVER DECREMENTS, CAUSING THE ALARMS TO NEVER GET UNSUPPRESSED RESULTING IN THE ISSUE. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED: THE CONDITION OF THE PATIENT WAS HEAVY HYPOTENSION. THEY GAVE SOME INFUSIONS TO RECOVER THE PATIENT TO STABLE HEALTH. THE INVESTIGATION HAS BEGUN. A FOLLOW UP REPORT WILL BE ISSUED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MONITOR DID NOT ALARM WHEN THE ARTERIAL SYSTOLIC AND MEAN PRESSURES WERE EXCEEDED OR NOT REACHED. THE ALARM LIMITS WERE SET CORRECTLY, THE ALARMS WERE ACTIVATED AND THE EMERGENCY BUTTON WAS NOT PRESSED. OTHER ALARMS SUCH AS HF AND O2 SATURATION ALARMED. THE PRESSURE CURVE WAS DISPLAYED CORRECTLY. DESPITE THE LOWER LIMIT WAS FALLEN BELOW, THERE WAS NO ALARM. ADDITIONAL INFORMATION WAS RECEIVED: THE CONDITION OF THE PATIENT WAS HEAVY HYPOTENSION. THEY GAVE SOME INFUSIONS TO RECOVER THE PATIENT TO STABLE HEALTH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MONITOR DID NOT ALARM WHEN THE ARTERIAL SYSTOLIC AND MEAN PRESSURES WERE EXCEEDED OR NOT REACHED. THE ALARM LIMITS WERE SET CORRECTLY, THE ALARMS WERE ACTIVATED AND THE EMERGENCY BUTTON WAS NOT PRESSED. OTHER ALARMS SUCH AS HF AND O2 SATURATION ALARMED. THE PRESSURE CURVE WAS DISPLAYED CORRECTLY. DESPITE THE LOWER LIMIT WAS FALLEN BELOW, THERE WAS NO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909704 INFINITY ACUTE CARE SYSTEM (M540) MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) CBK DRAEGER MEDICAL SYSTEMS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1