BEUDAMED
    FDA Adverse Event Death Summary report: N

    MD - HARDWARE

    MDR report key: 1832902 · Received September 13, 2010

    Report

    Report Number
    6000001-2010-03184
    Event Type
    Death
    Date Received
    September 13, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 17, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS CURRENTLY UNKNOWN WHAT INFUSION DEVICE WAS IN USE AT THE TIME OF THE PATIENT'S EXPIRATION. BAXTER HAS MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE RISK MANAGER AT THE FACILITY WHERE THIS EVENT OCCURRED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION AND RETRIEVE THE PUMP FOR EVALUATION WITHOUT SUCCESS. THE FACILITY HAS DECLINED TO PROVIDE ADDITIONAL INFORMATION RELATED TO THIS EVENT. NO FURTHER INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    ON AUGUST 17, 2010, BAXTER RECEIVED NOTIFICATION THAT THE REPORTER'S (B)(6) SON HAD PASSED AWAY. THE REPORTER STATED HER SON HAD GONE INTO THE HOSPITAL FOR ISSUES WITH HIS KIDNEY. THE HOSPITAL ADMINISTERED VANCOMYCIN INTRAVENOUSLY AND HER SON CODED. THEY WERE ABLE TO RESUSCITATE THE CHILD AND HE REMAINED IN THE HOSPITAL FOR TWO WEEKS. ON AN UNREPORTED DATE, WHILE ONE OF THE NURSES WAS PRESSING BUTTONS ON THE PUMP (UNKNOWN) THE PUMP WENT "BERSERK", CUTTING OFF THE FLUIDS AND HER SON CODED AGAIN AND EXPIRED. THE REPORTER DID NOT INDICATE THAT THIS INCIDENT WAS DIRECTLY RELATED TO A BAXTER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MD - HARDWARE PUMP, INFUSION FRN UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Death| H| R