FDA Adverse Event Death Summary report: N

ALARIS

MDR report key: 3164042 · Received June 7, 2013

Report

Report Number
3164042
Event Type
Death
Date Received
June 7, 2013
Date of Event
June 1, 2013
Report Date
June 7, 2013
Manufacturer
CAREFUSION 303, INC.
Product Code
FRN
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
VA, US

Narratives

Description of Event or Problem · 1

PATIENT WAS ADMITTED TO ED FOR EVALUATION OF WEAKNESS RELATED TO COMPLICATED MEDICAL HISTORY. INTUBATION OF PATIENT WAS NECESSARY TO ADDRESS CURRENT RESPIRATORY STATUS. A FENTANYL DRIP WAS ORDERED TO BE DELIVERED THROUGH CENTRAL VENOUS LINE FOR SEDATION. NURSE SET UP IV LINE AND APPROPRIATELY FED LINE THROUGH ALARIS MODULE ON 8015 ALARIS PC. ROLLER CLAMP CONTROL ON TUBING WAS IN THE OPEN POSITION. AS SHE CLOSED THE MODULE DOOR, THE CHANNEL ALARMED "CLOSE DOOR SAFETY CLAMP OPEN" AND THE NURSE WAS UNABLE TO CORRECT THE ERROR. NURSE REMOVED THE TUBING FROM THE MODULE AND BELIEVED THAT THE TUBING WOULD AUTOMATICALLY CLAMP OFF AS EXPECTED PER USUAL PROCESS WHEN PUMP WAS CORRECTLY FUNCTIONING. NURSE THEN WENT TO FIND A REPLACEMENT FOR THE MALFUNCTIONING PUMP. PATIENT SUBSEQUENTLY RECEIVED FREE FLOWING OVERDOSE OF FENTANYL ADMINISTRATION, COMPLICATING PATIENT CONDITION AND CONTRIBUTING TO PATIENT DEATH.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ADMINISTRATION OF IV MEDICATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
253631 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 10011274 *

Patients

Seq Age Sex Outcome Treatment
1 69 YR Death ALARIS 8015 SERIES PC