BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABACUS" SOFTWARE

    MDR report key: 686189 · Received March 10, 2006

    Report

    Report Number
    1419106-2006-00002
    Event Type
    Injury
    Date Received
    March 10, 2006
    Date of Event
    February 16, 2006
    Report Date
    February 16, 2006
    Manufacturer
    BAXA CORP.
    Product Code
    JQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO TPN BAGS MIXED ON THE EXACTA-MIX" 2400 (EM2400) COMPOUNDER HAD A HIGHEST-THAT-ANTICIPATED VOLUME OF THE CALCIUM GLUCONATE INGREDIENT. THE REPORT STATED THAT THE PAGS WERE INFUSED TO TWO NEONATAL PTS. THE FIRST TPN PT (BAG NUMBER 144) RECEIVED 12 HRS OF A 24-HR INFUSION (APPROXIMATELY 50% OF THE TOTAL SOLUTION) AND THE SECOND PT (BAG NUMBER 140) RECEIVED A SMALLER INFUSED VOLUME BEFORE THE TPN WAS DISCONTINUED. BAG NUMBER 144 WAS DISCONTINUED WHEN NURSE REPORTED DISCOLORATION OF THE PT'S HANDS. THIS PT WAS SUBSEQUENTLY INFUSED WITH FLUIDS AND IV LASIX. BAG NUMBER 140 WAS STARTED LATER, BUT ALSO DISCONTINUED, AND NO MED OR SURGICAL INTERVENTION WAS REQUIRED. THE INFUSION OF TPN WAS SUBSEQUENTLY DOSCONTINUED FOR ALL PTS. ACCORDING TO RISK MANAGEMENT STAFF, NEITHER PT SUFFERED PERMANENT ILLNESS OR INJURY AS A RESULT OF THE HIGHER-THAN-ANTICIPATED VOLUME OF CALCIUM. FOR BOTH BAGS, THE ABACUS" TPN CALCULATION SOFTWARE WAS USED FOR ORDER ENTRY AND CALCULATION OF THE INDIVIDUAL VOLUME FOR EACH INGRADIENT IN THE TPN SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABACUS" SOFTWARE TPN CALCULATION SOFTWARE JQP BAXA CORP. 8300-0047 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY Required Intervention