BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOUNDERS

    MDR report key: 2690341 · Received August 10, 2012

    Report

    Report Number
    6000001-2012-13113
    Event Type
    Injury
    Date Received
    August 10, 2012
    Date of Event
    July 1, 2012
    Report Date
    July 10, 2012
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    NEP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT. SHOULD ANY ADDITIONAL INFORMATION BE MADE AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS DEVICE IS CLASS II EXEMPT FROM HAVING A 510K NUMBER. ITS ADDITIONAL 510K NUMBER IS K961008.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PROBLEM COULD NOT BE CONFIRMED AND THE ROOT CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A BAXTER REPRESENTATIVE A CONDITION OF AN AUTOMIX COMPOUNDER UTILIZING AN ACCUSOURCE THAT WAS ALLEGED TO HAVE PUMPED THE WRONG SOLUTION, THAT LED TO THE INJURY OF AN UNKNOWN PATIENT. IT WAS REPORTED THAT APPROXIMATELY 100ML OF "THE WRONG SOLUTION" WAS INFUSED. THE FACILITY HAS QUARANTINED THE ACCUSOURCE. THE CURRENT STATE OF THE INVOLVED PATIENT IS UNKNOWN. ACCORDING TO THE FACILITY, THEY WERE ABLE TO REPRODUCE THIS CONDITION IN TESTING. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOUNDERS SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE - BUFFALO GROVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other