BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABACUS V3.2 ME

    MDR report key: 6698776 · Received July 10, 2017

    Report

    Report Number
    1416980-2017-05687
    Event Type
    Death
    Date Received
    July 10, 2017
    Date of Event
    February 20, 2017
    Report Date
    August 11, 2017
    Manufacturer
    BAXTER HEALTHCARE - ENGLEWOOD
    Product Code
    NEP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH REPORT # 3400300000-2017-000011. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THE PERIOPERATIVE PHARMACY SELECTED THE ¿NEW SOLUTION¿ PATHWAY INSTEAD OF THE ¿REPEAT SELECTED¿ PATHWAY TO ACCESS THE SAVED FORMULA. THE CAUSE OF THE EVENT WAS DETERMINED TO BE USER ERROR. THE INSTRUCTIONS PROVIDED WITH THE ABACUS V3.2 ME SOFTWARE PROVIDE DIRECTIONS ON HOW TO PROPERLY ACCESS FORMULAS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO DIED FOLLOWING A LIVER TRANSPLANT. IT WAS REPORTED THAT AN ORDER WAS PLACED FOR 5% ALBUMIN 250ML/NORMAL SALINE 750 ML IRRIGATION SOLUTION. IN PREPARING THIS ORDER USING THE ABACUS V3.2 ME AUTOMATED COMPOUNDER SOFTWARE, THE PERIOPERATIVE PHARMACY SELECTED THE ¿NEW SOLUTION¿ PATHWAY INSTEAD OF THE ¿REPEAT SELECTED¿ PATHWAY TO ACCESS THE SAVED FORMULA. THIS RESULTED IN GENERATION OF THE LABEL ¿NS 750ML FOR OR (LIVER TRANSPLANT)"; HOWEVER, SCANNING THE ASSOCIATED BAR CODE RESULTED IN THE PREPARATION OF A DEFAULT DILUENT FLUID OF STERILE WATER INSTEAD OF NORMAL SALINE. THE DISCREPANCY BETWEEN THE LABEL AND THE FLUID INGREDIENT LIST WAS NOT SUBSEQUENTLY RECOGNIZED IN A REVIEW OF A ¿MIX CHECK¿ REPORT. THE BAG CONTAINING STERILE WATER WAS SENT TO THE PHARMACY WHERE ALBUMIN 5% 250ML WAS ADDED AND THE PRODUCT WAS DISPENSED. THE SOLUTION WAS USED TO FLUSH A CADAVER LIVER IN A BASIN PRIOR TO TRANSPLANT. A PATIENT RECEIVED THE LIVER. THE PATIENT EXPERIENCED PRIMARY NON-FUNCTION OF THE TRANSPLANTED LIVER AND SUBSEQUENT DETERIORATION OF THEIR CLINICAL CONDITION (NOT FURTHER SPECIFIED). THREE DAYS AFTER THE TRANSPLANT, THE PATIENT DIED. A SUBSEQUENT PHARMACIST CHECK OF ANOTHER NORMAL SALINE 750ML BAG MADE BY THE AUTOMATED COMPOUNDER THE DAY AFTER THE TRANSPLANT REVEALED THAT THE CONTENTS CONTAINED STERILE WATER INSTEAD OF NORMAL SALINE. A THOROUGH EVALUATION BY THE CUSTOMER WAS CONDUCTED AND REVEALED THAT THE INCORRECT FORMULA HAD BEEN USED TO IRRIGATE THE LIVER USED IN THE TRANSPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480266 ABACUS V3.2 ME SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE - ENGLEWOOD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death