BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRIMUS

    MDR report key: 8119006 · Received November 30, 2018

    Report

    Report Number
    9611500-2018-00379
    Event Type
    Death
    Date Received
    November 30, 2018
    Date of Event
    November 20, 2018
    Report Date
    December 20, 2018
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    BSZ
    PMA / PMN Number
    K042607
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    DRÄGER RECEIVED THE INFORMATION THAT THE WORKSTATION WAS TESTED IN FOLLOW-UP OF THE EVENT BY AN INDEPENDENT EXPERT WHO STATED THAT THE DEVICE WAS FREE OF TECHNICAL FAULTS AT THE TIME OF EVENT. LOG FILE ANALYSIS CARRIED OUT BY THE MANUFACTURER CONFIRMS THIS - NO ENTRIES OF DEVICE-RELATED ISSUES WERE RECORDED FOR THE PERIOD IN QUESTION. THE FOLLOWING COULD FURTHER BE DETERMINED: THE DEVICE PASSED THE AUTOMATIC SELF-TEST IN THE MORNING OF THE DATE OF EVENT W/O DEVIATIONS. THE COMPLIANCE OF THE AIRWAY SYSTEM WAS MEASURED AT 3.5 ML/HPA WHICH IS COMPARATIVELY HIGH - TYPICAL VALUES ARE BETWEEN 0.5 AND 2.6 ML/HPA. THE VALUE IS AN INDICATION THAT A BREATHING CIRCUIT SET WITH A LENGTH AROUND 3 METERS OR MORE WAS CONNECTED AT THAT TIME. THE FIRST PROCEDURE OF THE DAY PERFORMED ON A (B)(6) CHILD WAS STABLE AND UNREMARKABLE. BEFORE THE PROCEDURE IN QUESTION WAS STARTED, NO NEW LEAK TEST OR OTHER CHECK WITH THE ENTIRE SYSTEM WAS PERFORMED. THE RESPECTIVE PROCEDURE WAS STARTED IN MANUAL VENTILATION MODE AT 10:56 SYSTEM TIME. FROM THE BEGINNING THE VENTILATION WAS RESTRICTED - THE DEVICE ALARMED FOR A LOW APPLIED MINUTE VOLUME WHILE THE AIRWAY PRESSURE WAS EXCEEDING THE ADJUSTED LIMIT. THE INSPIRATORY FIO2 WAS AT 25VOL% AT THE BEGINNING AND DECREASED CONTINUOUSLY DOWN TO 3VOL% MEASURED AT 11:10. ON THE OTHER HAND, MORE THAN 1.500 LITERS OF OXYGEN HAVE BEEN CONSUMED DURING THE WHOLE PROCEDURE WHICH WOULD EQUAL AN AVERAGE FLOW OF 14 L/MIN. THE ETCO2 VALUE INCREASED STEP BY STEP TO VALUES ABOVE 80 MMHG WITHIN THE SAME TIME. IN THE FOLLOWING, THE USER SWITCHED FORTH AND BACK BETWEEN MANUAL AND CERTAIN AUTOMATIC VENTILATION MODES BUT THIS OBVIOUSLY HAD NO POSITIVE EFFECT FOR THE PATIENT. THE PRIMUS CONTINUED TO ALARM FOR LOW INSPIRATORY O2, HIGH EXPIRATORY CO2, APNEA ETC. BETWEEN 11:23 AND 11:55 INSPIRATORY AND EXPIRATORY FIO2 VALUES WERE BOTH ON LEVEL OF NORMAL AIR BEFORE SUDDENLY AN INCREASE TO VALUES AROUND 40VOL% WAS DETECTED AT 11:58. ANOTHER INCREASE IN INSPIRATORY FIO2 TO 100VOL% WAS DETECTED AT 12:01 SYSTEM TIME. IN THE FOLLOWING THE VENTILATION PARAMETER STABILIZED WITH TIDAL VOLUMES AND AIRWAY PRESSURE READINGS IN THE EXPECTED RANGE. A REASONABLE EXPLANATION FOR THE COMBINATION OF PATIENT GAS READINGS AND FLOW/PRESSURE PARAMETER WOULD BE THAT THE PATIENT WAS NOT PNEUMATICALLY CONNECTED TO THE BREATHING SYSTEM OF THE DEVICE UNTIL THE INTERVENTION AT 11:58 WAS PERFORMED. IT IS NOT KNOWN TO DRÄGER WHAT EXACTLY WAS INITIATED BY THE USERS AT THAT TIME AND WHAT ALLOWED THE ESTABLISHING OF A STABLE VENTILATION IN THE FOLLOWING. THE FACT THAT THE FIRST PROCEDURE PERFORMED ON THE DATE OF EVENT WAS STABLE AND UNREMARKABLE IN REGARD TO VENTILATION REASONABLY SUGGESTS THAT THE PATIENT CIRCUIT HAS BEEN REPLACED PRIOR TO THE TREATMENT OF THE DECEASED PATIENT OR AT LEAST CHANGED IN ITS SETUP. IT CAN BE CONCLUDED THAT THE PRIMUS DETECTED THE IMPAIRMENTS IN VENTILATION DURING THE COURSE OF EVENT AND POSTED THE CORRESPONDING ALARMS. GAS READINGS CLEARLY INDICATED THE UNDER-SUPPLY OF THE PATIENT WITH OXYGEN. THERE IS NO ISSUE WITH THE PRIMUS WORKSTATION THAT WOULD REQUIRE REPAIR OR CORRECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT BE VENTILATED DURING THE INDUCTION OF ANESTHESIA. THE USERS DID NOT ALLEGE A DEVICE MALFUNCTION SINCE MANUAL VENTILATION WITH AN AMBU BAG FAILED AS WELL. THE PATIENT DIED ONE DAY AFTER THE EVENT. THIS REPORT IS BEING FILED BECAUSE A USE ERROR CAN'T BE FULLY RULED OUT DUE TO MISSING INFORMATION.

    Description of Event or Problem · 1

    PLEASE REFER TO INITIAL MFR. REPRT #9611500-2018-00379.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959830 PRIMUS ANESTHESIA UNITS BSZ DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death