BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIDENTIFIED BREATHING CIRCUIT

    MDR report key: 2195579 · Received August 1, 2011

    Report

    Report Number
    2183502-2011-00550
    Event Type
    Death
    Date Received
    August 1, 2011
    Date of Event
    January 30, 2007
    Report Date
    July 26, 2011
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    CAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS REC'D VIA ASSISTANT ATTORNEY GENERAL FOR THE STATE OF (B)(6) WHO WAS SEEKING A MONETARY CONTRIBUTION TOWARD A MEDICAL NEGLIGENCE CASE THAT THE STATE HAD SETTLED. DEVICE EVAL: CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    REC'D NOTICE FROM THE OFFICE OF THE ATTORNEY GENERAL OF THE STATE OF (B)(6) THAT STATED: "THE STATE OF (B)(6) HAS JUST SETTLED A CLAIM BROUGHT AGAINST IT BY THE ESTATE OF (B)(6). THE ESTATE CLAIMED THAT NEGLIGENCE ON THE PART OF STAFF AT THE UNIVERSITY OF (B)(6) HOSPITALS AND CLINICS CAUSED (B)(6) DEATH ON (B)(6) 2007. (B)(6) WAS BEING TRANSPORTED TO THE (B)(6) FACILITY FROM (B)(6), BY THE (B)(6) AIR AMBULANCE WHEN HIS OXYGEN SUPPLY WAS INTERRUPTED SHORTLY AFTER LANDING AT THE (B)(6). OUR INVESTIGATION SHOWED THAT HIS VENTILATOR TUBING HAD CRACKED AND WAS ALLOWING OXYGEN TO ESCAPE FROM THE SYSTEM, CAUSING (B)(6) ULTIMATELY FATAL BRAIN INJURY. THE MATTER WAS SETTLED FOR (B)(6). BY THIS LETTER, WE ARE REQUESTING CONTRIBUTION FROM SMITHS MEDICAL PM, INC., BECAUSE THE VENTILATOR TUBING IN QUESTION WAS MANUFACTURED AND SUPPLIED TO THE (B)(6) BY SMITHS. PLEASE FORWARD THIS LETTER, IF NECESSARY, TO YOUR LEGAL DEPT OR OTHER APPROPRIATE LOCATION. I'LL LOOK FORWARD TO HEARING BACK FROM YOU OR YOUR REPRESENTATIVE SOON." ON (B)(6) 2011, (B)(6), ASSISTANT ATTORNEY GENERAL FOR THE STATE OF (B)(6) WAS CONTACTED FOR MORE INFO AND CLARIFICATION. THE FOLLOWING IS A SUMMARY OF THE CONVERSATION THAT OCCURRED BETWEEN (B)(6) AND SMITHS MEDICAL LEGAL DEPT. ON (B)(6) 2007, (B)(6), AN EXTREMELY ILL (B)(6) MAN WAS BEING TRANSFERRED VIA HELICOPTER FROM (B)(6) HOSPITAL TO THE SICU AT (B)(6). THE HELICOPTER HAD ITS OWN VENTILATOR SYSTEM, AND (B)(6) WAS PLACED ON THIS PRIOR TO LEAVING (B)(6). UPON ARRIVAL, (B)(6) WAS BEING TRANSFERRED FROM THE HELICOPTER CART TO THE HOSPITAL CART. THE VENTILATOR TUBING BECAME CAUGHT BETWEEN THE TWO CARTS. (B)(6) REPORTS THIS IS WHEN THEY BELIEVE THE TUBING BECAME DAMAGED; THE DAMAGE WENT UNNOTICED UNTIL HE WAS ADMITTED TO SICU. IT WAS REPORTED THAT THE PT EXPIRED ON (B)(6) 2007 DUE TO WHAT WAS REPORTED AS A BRAIN INJURY. (B)(6) REPORTS THAT THE (B)(6) DEPT OF JUSTICE, ON BEHALF OF THE EMT SERVICE, CHOSE TO SETTLE WITH THE DECEDENT'S FAMILY FOR (B)(6). IT WAS REPORTED THAT THE HOSPITAL DID NOT KEEP OR TEST THE PRODUCT USED AT THE TIME OF THE INCIDENT. SPURIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIDENTIFIED BREATHING CIRCUIT CAI-CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI SMITHS MEDICAL INTERNATIONAL LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death