BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 2081374 · Received April 28, 2011

    Report

    Report Number
    2016493-2011-00045
    Event Type
    Injury
    Date Received
    April 28, 2011
    Manufacturer
    CAREFUSION
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S INITIAL REPORT DATE: 4/28/2011. (B)(4). ADD'L INFO: ADD'L INFO WAS REQUESTED, BUT THE CUSTOMER DECLINED TO PROVIDE ANY FURTHER INFO AS TO WHICH HOSP THE ALLEGED EVENT OCCURRED. IN ADDITION, NO INFO WAS PROVIDED ON THE CITY OR ANY CONTACT INFO. THEREFORE, IT IS UNK TO CAREFUSION WHERE OR IF THIS EVENT OCCURRED. THERE HAVE BEEN NO REPORTS OF THIS INJURY OR SIMILAR CIRCUMSTANCES TO CAREFUSION.

    Description of Event or Problem · 1

    ANECDOTAL INFO RECEIVED FROM A CUSTOMER REPORTING OF AN EVENT IN NEW YORK INVOLVING A PYXIS DEVICE AND FAILURE TO ACCESS MEDICATIONS THAT RESULTED IN ANOXIC BRAIN INJURY TO THE PT. THE CUSTOMER REPORTED THE EVENT OCCURRED IN A PACU FOLLOWING A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN NA BRY CAREFUSION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening