BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESUS BAG ADULT MANUAL 6/CS

    MDR report key: 3103297 · Received May 9, 2013

    Report

    Report Number
    8030673-2013-00043
    Event Type
    Death
    Date Received
    May 9, 2013
    Date of Event
    February 10, 2013
    Report Date
    April 9, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BTM
    PMA / PMN Number
    K924610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED FOR EVALUATION WITHOUT A MASK. THE PRODUCTION RECORD FOR THE LOT NUMBER REPORTED WAS REVIEWED AND NO ISSUES WERE OBSERVED. THE PRODUCT WAS FUNCTIONALLY TESTED BY CAREFUSION QUALITY PERSONNEL AND FLOW WAS CONFIRMED. ADDITIONALLY, NO LEAKS WERE FOUND WITHIN THE PRODUCT. THE MATERIALS OF THE RESERVOIR BAG WERE REVIEWED AND NO NON-CONFORMITIES WERE OBSERVED. SINCE THE ISSUE REPORTED CANNOT BE CONFIRMED (THE SAMPLE DID NOT PRESENT ANY ANOMALIES), IT¿S NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE ISSUE REPORTED. AT THIS TIME, NO CORRECTIVE ACTION WILL BE IMPLEMENTED SINCE THE FAILURE REPORTED WAS NOT CONFIRMED DURING SAMPLE EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED:  ON (B)(6) 2013 AN AIRLIFE/CAREFUSION ADULT MANUAL RESUSCITATOR WAS USED DURING A CODE BLUE.  AFTER GRABBING THE BAG AND PULLING IT OUT OF THE BAG, IT WAS FOUND TO BE MISSING A MASK (A MASK WAS THEN TAKEN FROM AN AMBU LOCATED AT THE NEXT BED).  WITH THE OXYGEN LINE CONNECTED TO WALL OXYGEN FLOWMETER ON 15 L/M, IT WAS THEN NOTICED THE RESERVOIR BAG WAS NOT FILLING AND THE PATIENT WAS NOT GETTING ENOUGH OXYGEN.  AFTER MAKING SURE THE BAG WAS STRAIGHT OUT FROM THE AMBU AND THE OXYGEN FLOW WAS ON AND IT STILL DID NOT FUNCTION, THE RESUSCITATOR WAS REPLACED WITH ANOTHER PRODUCT, WHICH FUNCTIONED PROPERLY.  AFTER THE CODE, THE MALFUNCTIONING RESUSCITATOR WAS EVENTUALLY PLACED IN A BAG.  I ALSO CHECKED THE REMAINDER STOCK OF AIRLIFE RESUSCITATORS, WHICH DID HAVE MASK AND WORKING RESERVOIRS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013: RESPIRATORY THERAPY MANAGER STATED THAT DURING THE CODE BLUE A MASK WAS MISSING FROM AN AIRLIFE 2K8004 PRODUCT. HE STATED THAT HE WAS NOT SURE IF SOMEONE INTENTIONALLY TOOK THE MASK OUT AS THE BAG WAS NOT SEALED AND COULDN'T CONFIRM IT WAS ACTUALLY MISSING OR SOMEONE TOOK IT. THE CODE BLUE TOOK PLACE IN THE ER AND ONCE HE REALIZED THE MASK WAS MISSING HE REACHED TO THE BED NEXT DOOR AND GRABBED A MASK FROM A 'LIFESAVER HUDSON' RESUSCITATION BAG. HE STATED THE PATIENT SPO2 DROPPED TO THE 60'S 'NUMBERS I DON'T WANT TO SEE.' HE NOTICED THE RESERVOIR BAG WAS NOT INFLATING AND DOUBLE CHECKED THE OXYGEN TUBING TO THE FLOWMETER, HE STATED IT HAD A 'SNUG FIT.' HE DOESN'T RECALL THE CHEST RISING AS IN A CODE BLUE SITUATION, 'THINGS HAPPEN QUICKLY AND THE PROBLEM WAS OXYGENATION.' HE GRABBED THE LIFESAVER HUDSON RESUS BAG (THE ONE HE TOOK THE MASK FROM) AND USED THIS FOR THE REMAINDER OF THE CODE WITH NO ISSUES. THERE ARE NO CASES OF THE TUBING POPPING OFF. HE STATED THAT SINCE IT'S A SMALL HOSPITAL (CRITICAL PATIENTS ARE NOT ADMITTED) THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL IN A MATTER OF HOURS. WHEN ASKED ABOUT THE PATIENT OUTCOME, HE STATED HE HEARD THE PATIENT HAD EXPIRED, BUT DOESN'T BELIEVE IT WAS DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203671 RESUS BAG ADULT MANUAL 6/CS VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM CAREFUSION 2K8004 0000430741

    Patients

    Seq Age Sex Outcome Treatment
    1 Death