BEUDAMED
    FDA Adverse Event Death Summary report: N

    MASK,ADULT,OXYGEN,MANUAL,RESUSITATOR,ST PBDS ONLY

    MDR report key: 2895378 · Received January 3, 2013

    Report

    Report Number
    8030673-2013-00001
    Event Type
    Death
    Date Received
    January 3, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BTM
    PMA / PMN Number
    K924610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE PATIENT'S CAUSE OF DEATH WAS REPORTED AS ACUTE RESPIRATORY FAILURE WITH A HISTORY OF CHRONIC INTERSTITIAL LUNG DISEASE WITH FIBROSIS. EVALUATION SUMMARY: ONE SAMPLE WAS RETURNED FOR EVALUATION. UPON REVIEW OF THE SAMPLE, THE OCCLUDED CONDITION IN THE CONNECTOR WAS CONFIRMED. A PRODUCTION RECORD WAS REVIEWED AND IT REVEALED THAT THE OCCLUDED PART WAS IDENTIFIED IN THE MOLDING AREA. THE MOLD WAS REPAIRED TO PREVENT ANY FUTURE OCCURRENCES. AS A PREVENTIVE ACTION, ALL PERSONNEL WERE NOTIFIED ABOUT THIS INCIDENT. AN IMPLEMENTED PROJECT PLAN INCLUDED REPAIRING AND MODIFYING THE MOLDING TOOL TO AVOID MAIN CORE PINS SHUT OFF IN THE FLUID PATH. PREVENTIVE MAINTENANCE BY A TOOLING SHOP TECHNICIAN WILL INCLUDE SPECIFIC ACTIVITIES TO IDENTIFY, EVALUATE, AND PREVENT MOLD WEAR AND TEAR CONDITIONS IN THE FUTURE.

    Additional Manufacturer Narrative · 1

    REPORT NUMBER: 1423507-02/04/09/2013/2013-003-R. CAREFUSION HAS DECIDED TO INITIATE A VOLUNTARY RECALL/REMOVAL OF THE ADULT AIRLIFE RESUSCITATION BAGS THAT WAS INITIATED ON APRIL 22, 2013 AS A REMEDIAL ACTION TO MITIGATE PATIENT RISK.

    Additional Manufacturer Narrative · 1

    (B)(4)- DEVICE IS IN THE PROCESS OF BEING SENT TO MANUFACTURING PLANT. UPON COMPLETION OF CAREFUSION'S INVESTIGATION, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER DISCOVERED THAT THE END THAT HOOKS UP TO THE O2 REGULATOR IS OCCLUDED,  HE GENTLY TRIED TO PUT A PAPERCLIP IN THE END AND IT IS COMPLETELY BLOCKED.  MORE INFORMATION RECEIVED FROM CUSTOMER ON (B)(6) 2012: THE PATIENT WAS (B)(6) AT THE TIME OF EVENT. HISTORY OF COPD, PATIENT WAS NO CODE PER HIS REQUEST AFTER THIS.  TIME FRAME OF EVENT : THE PATIENT'S CONDITION DETERIORATED AND RAPID RESPONSE TEAM CALLED, O2 SAT IN 70'S. MENTAL CONFUSION INCREASED AND SAT DROPPED TO 60. PATIENT TRANSFERRED TO ICU IMMEDIATELY, CODE BLUE SHORTLY THEREAFTER BIPAP PLACED AND RESPIRATORY STATUS IMPROVED. PATIENT EXPIRED FOLLOWING DAY. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. "THE INTEGRITY WAS QUESTIONED DURING THE TRANSFER TO THE ICU AS THE PT'S O2 SATS WERE NOT IMPROVING BUT WORSENING WHEN THE RN AND RT WERE BAGGING THE PT. ONCE THE PT REACHED THE ICU, THE RN VERIFIED THIS BY TURNING UP THE OXYGEN ON THE WALL AND ATTEMPTING TO PLUG IN. THE TUBING POPPED OFF WHEN PLUGGED INTO A FLOW METER THAT PROVIDED HIGHER FLOW. IT DID NOT POP OFF WHEN PLUGGED INTO THE PORTABLE TANK THAT PROVIDED A LOWER FLOW RATE. THE RESERVOIR BAG DID NOT INFLATE DURING THE TRANSFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3455 MASK,ADULT,OXYGEN,MANUAL,RESUSITATOR,ST PBDS ONLY VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM CAREFUSION 2K8004-CS 0000355673

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death