BEUDAMED
    FDA Adverse Event Death Summary report: N

    BREATHING SYS MAPLESONC,W APL VALVE

    MDR report key: 5851011 · Received August 5, 2016

    Report

    Report Number
    8030673-2016-00201
    Event Type
    Death
    Date Received
    August 5, 2016
    Date of Event
    March 25, 2016
    Report Date
    November 7, 2016
    Manufacturer
    CAREFUSION/BD
    Product Code
    BZD
    PMA / PMN Number
    K911465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION HAS REACHED OUT TO THE CUSTOMER AND REQUESTED RETURN OF THE COMPLAINT DEVICE FOR FURTHER INVESTIGATION. TO DATE, CAREFUSION HAS NOT RECEIVED THE COMPLAINT DEVICE BACK FROM THE CUSTOMER. A FOLLOW UP EMDR WILL BE SUBMITTED BY CAREFUSION SHOULD THE COMPLAINT DEVICE BECOME AVAILABLE FOR EVALUATION OR IF ADDITIONAL INFORMATION IS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: ONE SAMPLE WAS RECEIVED AND EVALUATED WITH VISUAL, FUNCTIONAL, AND RESISTANCE TESTING. DURING THE VISUAL INSPECTION THE REPORTED BENT OXYGEN TUBING WAS OBSERVED. A FUNCTIONAL FLOW AND LEAK TEST WAS THEN PERFORMED. AS A RESULT IT WAS FOUND THAT THIS BENT CONDITION DOES NOT PROVOKE ANY FUNCTIONAL ANOMALIES WITH THE PRODUCT. THE CIRCUIT ALSO PASSED THE LEAK TEST. THE RESISTANCE TEST TO KINKING FOUND A PERMISSIBLE FLOW OF 90%. THIS IS ABOVE THE REQUIRED 75%. WITH THESE FINDINGS THE REPORTED FAILURE MODE WAS NOT CONFIRMED AS THE SAMPLE DID NOT PRESENT ANY ANOMALIES. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE REPORTED LOT NUMBER AND NO ISSUES WERE FOUND. AT THIS TIME NO CORRECTIVE ACTIONS WILL BE IMPLEMENTED.

    Description of Event or Problem · 1

    A COLLAPSED PATIENT WAS BEING RESUSCITATED IN THE ED. PATIENT WAS INTUBATED AND BEING VENTILATED BY HAND. NOTED OXYGEN TUBING ATTACHED TO WATERS' SYSTEM WAS KINKED AND OBSTRUCTED. PATIENT'S OXYGEN SATURATION WAS ONLY 70% AND THE ARTERIAL OXYGEN WAS CORRESPONDINGLY LOW. IF THE TUBE WAS NOT SUPPORTED, IT RE-KINKED IMMEDIATELY. THIS WAS NOT NOTICED BY THE ANESTHETIST, ED DOCTOR, ED NURSES, OR THE ED TEAM LEADER WHO WERE OCCUPIED WITH OTHER ELEMENTS OF THE RESUSCITATION. THE PROBLEM WAS POTENTIALLY THE CAUSE OF THE LOW SATURATION OR AT LEAST CONTRIBUTORY. IT ALSO IMPEDED VENTILATION AS THE BAG WAS NOT INFLATING AS IT SHOULD, EVEN THOUGH THE APL VALVE WAS FULLY TIGHTENED. ADDITIONAL INFORMATION WAS OBTAINED FROM (B)(6), PATIENT WAS VERY HYPOXIC, BUT THIS IMPROVED WITH A CHANGE OF THE SYSTEM, WHICH ON REFLECTION MAY HAVE BEEN COINCIDENTAL, BUT THIS IS NOT COMPLETELY CLEAR. AFTER CONSULTATION WITH THORACIC SURGERY, NEUROSCIENCE, AND THE STROKE TEAM RESUSCITATION WAS DISCONTINUED AND THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502167 BREATHING SYS MAPLESONC,W APL VALVE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD CAREFUSION/BD 9818365

    Patients

    Seq Age Sex Outcome Treatment
    1 Death