BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY ACS WORKSTATION NC

    MDR report key: 6816725 · Received August 24, 2017

    Report

    Report Number
    9611500-2017-00253
    Event Type
    Injury
    Date Received
    August 24, 2017
    Date of Event
    August 9, 2017
    Report Date
    August 24, 2017
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    PMA / PMN Number
    K093632
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN CHECKED ACCORDING TO MANUFACTURER PREVENTIVE MAINTENANCE SCHEDULE AND IT PASSED WITHOUT PROBLEMS. AS ALREADY STATED BY THE CUSTOMER NO TECHNICAL DEVICE PROBLEM OCCURRED. DRÄGER DID NOT DECLARE COMPATIBILITY OF ITS VENTILATOR WITH THE SOKINOX NO ADMINISTRATION DEVICE AS WELL AS THE SOKINOX NO ADMINISTRATION CIRCUIT AND THE BREATHING CIRCUIT FISHER AND PAYKEL MODEL RT 265. THEY ARE NOT PART OF THE APPROVED ACCESSORIES LIST. DURING THE MENTIONED APPLICATION TRAINING THE GENERAL NECESSITY TO USE ADAPTERS WAS DISCUSSED AND QUESTIONED BY DRÄGER. DRÄGER DID NOT ADVISE THE CUSTOMER REGARDING THE USE OF ADAPTERS DURING NO APPLICATION. THE NO USAGE WAS NOT DISCUSSED WITH ANY DRÄGER EMPLOYEE. THEREFORE WE CONCLUDE THAT THERE WAS NO MALFUNCTION OF A DRÄGER DEVICE OR APPROVED ACCESSORY, THE DISCONNECTION WAS ALARMED CORRECTLY.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED TO (B)(6): "AT 2 AM, NO ADMINISTRATION SYSTEM IS SETUP AND PLUGGED IN THE VN500 BREATHING CIRCUIT. THE SOKINOX NO ADMINISTRATION CIRCUIT HAS MODEL#6884473 AND BATCH#6884473, EXP 01/08/2019; THE MANUFACTURER IS MAQUET BUT IT WAS ORDERED AT AIR LIQUIDE SANTÉ WITH PART#178612. ON THE VENTILATOR BREATHING CIRCUIT THERE ARE 2 ADAPTERS (MADE OF A RIGID PLASTIC PART AND A FLEXIBLE ONE). THESE ADAPTERS ARE AVAILABLE IN THE KIT ¿CIRCUIT PÉDIATRIQUE BI-CHAUFFÉ+HUMIDIFICATION CHAMBER¿ FROM FISHER AND PAYKEL MODEL#RT 265. WHEN USING THE NO ADMINISTRATION SYSTEM CIRCUIT, THE 2 ADAPTERS ARE NOT NECESSARY, ACCORDINGLY TO THE DRAEGER APPLICATION SPECIALIST. THIS INFORMATION WAS TAUGHT ON JUNE 28TH 2017 TO THE STAFF DURING A VN500 APPLICATION TRAINING). THE CIRCUIT WAS THEN SETUP WITHOUT THE 2 ADAPTERS. MEANWHILE FOR THIS CHILD, AFTER MOUNTING THE SOKINOX (INSTALLED IN THE CARE UNIT IN 08/2016), THE BREATHING CIRCUIT WITHOUT ADAPTERS FITS WELL WITH THE SOKINOX SETUP, BUT THE INSP/EXP PRESSURE FROM THE VENTILATOR (AND THE WEIGHT OF THE NO CIRCUIT?), CAUSED THE INSP BRANCH TO DISCONNECT LEADING TO A VERY LOW SPO2 OF THE CHILD. AT THE SAME TIME AN ASY HAPPENED, BUT WE ARE NOT ABLE TO LINK IT TO THE SPO2 DROP. THE BREATHING CIRCUITS USED WERE NOT DAMAGED, THE NURSES SAYS. THE VENTILATOR, MONITOR AND THE SOKINOX SYSTEM WERE READY TO USE, FROM A PREVENTIVE MAINTENANCE POINT OF VIEW." THE CUSTOMER REPORTED: "STATE OF HEALTH OF THE PATIENT DETERIORATED. MEANWHILE WE CAN¿T LINK THE EVENT TO THE STATE OF HEALTH DETERIORATION, BETWEEN THE 1ST RESUSCITATION AT 4H51AM AND THE DEATH LATER IN THE DAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596528 INFINITY ACS WORKSTATION NC VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC CBK DRÄGERWERK AG & CO. KGAA N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening