FDA Adverse Event Summary report: N

INVANZ MINI BAG PLUS

MDR report key: 2171958 · Received July 18, 2011

Report

Report Number
2171958
Date Received
July 18, 2011
Date of Event
July 10, 2011
Report Date
July 18, 2011
Manufacturer
MERCK AND COMPANY, INC
Product Code
KPE
Report Source
User Facility report
Reporter Location
CA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

NURSE FORGOT TO RECONSTITUTE THE MERCK INVANZ MINI BAG PLUS BY SQUEEZING THE POWDERED INVANZ FROM THE ACCOMPANYING MEDICATION VIAL INTO THE 100ML SALINE BAG. SHE HUNG THE UN-RECONSTITUTED MEDICATION BAG AND INITIATED THE INFUSION. THE PATIENT NEVER RECEIVED THE INVANZ DOSE, WHICH SHE REQUIRED FOR TREATMENT OF ACUTE SEPSIS. THE OMISSION WAS NOT DISCOVERED FOR 24 HOURS DESPITE TWO NURSING HAND-OFFS THAT INCLUDE LINE CHECKS BECAUSE THE MANUFACTURER'S LABEL OBSCURES THE VIEW OF THE VIAL'S CONTENTS. THE PATIENT BECAME CRITICALLY ILL AND WAS TRANSFERRED TO THE ICU FOR TWO DAYS. SHE IS NOW RECOVERING. THE SAME FORM OF OMISSION ERROR HAS OCCURRED A FEW TIMES PREVIOUSLY WITH THE MINI BAG PLUS SET UP AND IS DIFFICULT TO DETECT DUE TO THE MANUFACTURER'S OBSCURING LABEL. A SAFER SYSTEM IS NEEDED, ONE THAT WOULD EASILY ALERT THE NURSE THAT THE MEDICATION HAS BEEN RECONSTITUTED, SUCH AS A WATER SENSITIVE STRIP IN THE VIAL THAT TURNS COLOR WHEN THE SALINE IS MIXED INTO THE VIAL. OR A NON-TOXIC COLORING ADDITIVE TO THE INVANZ POWDER THAT CAUSES THE RECONSTITUTED SOLUTION TO BE CLEARLY DIFFERENT THAN THE UNMIXED SALINE SOLUTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 INVANZ MINI BAG PLUS CONTAINER, IV KPE MERCK AND COMPANY, INC * 2014270

Patients

Seq Age Sex Outcome Treatment
1 53 YR