BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT

    MDR report key: 2930249 · Received January 25, 2013

    Report

    Report Number
    2050001-2013-00001
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    May 3, 2012
    Report Date
    December 26, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL ATTEMPTS IT IS UNCLEAR IF THIS PRODUCT WAS MANUFACTURED BY CAREFUSION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP WILL BE SENT.

    Description of Event or Problem · 1

    CAREFUSION WAS CONTACTED BY (B)(6) ON BEHALF OF (B)(6). (B)(6) INQUIRED ON THE POSSIBLE USES THE CAREFUSION "TRACH TEE" ADAPTOR. (B)(6) INFORMED CAREFUSION OF AN INCIDENT REPORTED. IT WAS STATED: "A PATIENT WAS BEING TRANSPORTED TO RECOVERY POST-OP WITH THE TRACH TEE ATTACHED TO THEIR ENDOTRACHEAL TUBE WITH SUPPLEMENTAL OXYGEN ON ONE SIDE AND A 6 INCH PIECE OF CORRUGATED BREATHING CIRCUIT ON THE OTHER SIDE. DURING THE TRANSFER, THE 6 INCH PIECE OF TUBING FELL OFF OF THE TEE AND A NURSE MISTAKENLY ATTACHED WALL OXYGEN INSTEAD OF THE OPEN ENDED 6 INCH PIECE, THEREBY BOTH ENDS OF THE TEE WERE DELIVERING OXYGEN WITHOUT A MEANS FOR THE PATIENT TO EXHALE. THE PATIENT SUFFERED ANOXIC BRAIN INJURY. NO RESPIRATORY THERAPISTS WERE INVOLVED IN THE INCIDENT AND SHE HAD NO IDEA WHY PHYSIOLOGIC MONITORING DID NOT ALARM. THE FACILITY BROUGHT IT TO THEIR ATTENTION AS A MISCONNECTION. THE RISK MANAGER AT THE FACILITY INDICATED THAT THEY UNDERSTOOD IT WAS CLEARLY USER ERROR AND THAT NUMEROUS ERRORS CONTRIBUTED. NONETHELESS, THEY NOW TAPE THE 6 INCH PIECE OF CORRUGATED TUBING ONTO THE TEE AS STANDARD PRACTICE AND HAVE ALSO CONDUCTED A STAFF TRAINING PROGRAM. THEY ASSUME THAT WALL O2 WAS SET UP TO SWITCH THE PATIENT OFF THE PORTABLE WHEN ARRIVING IN RECOVERY". THE HOSPITAL WAS CONTACTED REGARDING THE ISSUE. (B)(6) CONFIRMED THE INCIDENT WITH A "TRACH TEE" ADAPTER WHICH OCCURRED (B)(6) 2012. THE PRODUCT CODE AND LOT NUMBER WAS NOT PROVIDED. BASED ON THE PRODUCT DESCRIPTION, IT COULD POSSIBLY BE CAREFUSION PRODUCT (B)(4) (VERSO T ACCESS ADAPTOR). (B)(6) PROVIDED THE FOLLOWING EVENT DESCRIPTION: "A PATIENT UNDERWENT SURGERY AND WAS INTUBATED WITH A TRACH TEE ADAPTER IN PLACE AND WAS TRANSFERRED TO THE RECOVERY ROOM. THE PORTABLE OXYGEN FOR TRANSFER REMAINED IN PLACE ON ONE SIDE OF THE TRACH TEE ADAPTER AND ANOTHER OXYGEN SOURCE FROM CORRUGATED TUBING WAS CONNECTED TO THE OTHER SIDE OF THE TEE ADAPTER BLOCKING ANY WAY OF EXHALATION. THIS RESULTED IN ANOXIC BRAIN INJURY". A MEDWATCH REPORT (B)(4) WAS ALSO RECEIVED FROM THE FDA IN REGARDS TO THIS REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35977 UNKNOWN PRODUCT CAI CAREFUSION UNK - AIRLIFE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability