BEUDAMED
    FDA Adverse Event Death Summary report: N

    CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 1754258 · Received June 3, 2010

    Report

    Report Number
    1820334-2010-00251
    Event Type
    Death
    Date Received
    June 3, 2010
    Date of Event
    April 23, 2010
    Report Date
    May 4, 2010
    Manufacturer
    COOK INC
    Product Code
    DRE
    PMA / PMN Number
    K882796
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), PRODUCT DID NOT FUNCTION AS INTENDED. EVENT IS UNDER INVESTIGATION AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6), THE PHYSICIAN PLACED A SHILEY TRACH TUBE USING A COOK BLUE RHINO PERC TRACH INTRODUCER TRAY AT THE BEDSIDE OF A PT IN THE ICU. WITHIN ONE HOUR AFTER INSERTION, THE PT WAS OBSERVED NOT VENTILATING WELL AS EVIDENCED BY PEAK PRESSURES AND 90% SPO2 SATURATION RATE ON 100% OXYGEN. THE "TEAM" ASSEMBLED BACK AT THE PT'S BED TO FIGURE OUT WHAT WAS HAPPENING WITH THE PT'S SATURATION LEVELS. MANY EVENTS HAPPENED AT THE TIME INCLUDING LOOSENING THE AIRWAY AND ULTIMATELY RESULTING IN THE PT EXPERIENCING CARDIAC ARREST. ON (B)(6), THE FAMILY MADE AN INFORMED DECISION TO STOP VENTILATION, DUE TO THE MENTATION CHANGES IN THE PT. THE PT PASSED AWAY THEREAFTER. ADDITIONAL INFO WAS RECEIVED ON 05/20/2010 (FROM THE MEDWATCH REPORT). ON (B)(6) 2010 A PT (B)(6), AN (B)(6) MALE, WAS ADMITTED TO THE HOSPITAL WITH INCREASING SHORTNESS OF BREATH AND PALPITATIONS. HIS HISTORY WAS SIGNIFICANT FOR T-CELL LYMPHOMA, STATUS POST CHEMOTHERAPY. DURING THE COURSE OF THE HOSPITALIZATION, THE PT'S RESPIRATORY STATUS DECLINED TO THE POINT WHERE DEVELOPED RESPIRATORY FAILURE. ON (B)(6)2010, THE PHYSICIAN ORDERED AND PERFORMED A TRACHEOSTOMY PLACEMENT WHILE THE PT WAS IN THE ICU AS A RESULT OF THE PT'S WORSENING PULMONARY STATUS. THE #8 SHILEY TRACHEOSTOMY TUBE WAS PACKAGED AS PART OF A TRACH KIT PROVIDED BY COOK MEDICAL AND WAS A CUFFED SHILEY TRACHEOSTOMY KIT WHICH OUR TRACKING SYSTEM SHOWS TO HAVE BEEN LOT# 2438887. THE TRACH WAS EXPLANTED AND REPLACED BY ANOTHER TRACH TUBE BY THE PHYSICIAN AS A RESULT OF INEXPLICABLE AIR LOSS WHICH WAS NOTED BY NURSES AND RESPIRATORY THERAPISTS AFTER THE TRACH TUBE WAS INITIALLY PLACED. DURING THE PROCESS OF EXPLANTING AND REPLACEMENT, THE PT DEVELOPED WORSENING RESPIRATORY DISTRESS, CARDIAC ARREST AND CPR WAS INITIATED. UNFORTUNATELY, THE PT PASSED AWAY ON (B)(6) 2010. THE HOSPITAL RECEIVED NOTICE OF A RECALL COOK TRACHEOSTOMY KITS, LOT# 2438887, AFTER THIS EVENT. THE PT EXPERIENCED CARDIAC ARREST - THE FAMILY MADE AN INFORMED DECISION TO STOP VENTILATION DUE TO THE MENTATION CHANGES IN THE PT; THE PT PASSED AWAY THEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK INC NA 24388887

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death