BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXA

    MDR report key: 2103050 · Received May 24, 2011

    Report

    Report Number
    2103050
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BAXA
    Product Code
    NEP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWENTY FOUR WEEK PRETERM INFANT BORN BY C-SECTION SECONDARY TO PLACENTAL ABRUPTION; REQUIRED INTUBATION/VENTILATION AND TPN FOR NUTRITION; INFANT HAD HYPERGLYCEMIA THAT WAS DUE TO HIGH GLUCOSE IN THE TPN; DISCOVERED THAT THE TPN COMPOUNDER DELIVERED DEXTROSE IN THE FINAL FLUSH OF TUBING WHICH WAS CAUSING THE ELEVATED BLOOD GLUCOSE VALUES FOR THE INFANT; BLOOD GLUCOSE REACHED 1200; TREATED WITH INSULIN AND WAS 360 ON (B)(6)-2011; BLOOD GLUCOSE REMAINED STABLE PRIOR TO EXPIRATION 05-06-2011; CAUSES OF DEATH: SEVERE PERSISTENT HYPOTENSION, SEVERE INTRACTABLE METABOLIC ACIDOSIS, ELECTROLYTE IMBALANCE; PULMONARY HEMORRHAGE, PRESUMED SEPSIS MILD GRADE I IVH ON THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXA TPN COMPOUNDER NEP BAXA MICROMACRO 071AR-RS232

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Life Threatening| R