FDA Adverse Event Malfunction Summary report: N

ATLANTA BIOMEDICAL CORPORATION (ABC) INFUSION PUMP

MDR report key: 5382476 · Received January 21, 2016

Report

Report Number
5382476
Event Type
Malfunction
Date Received
January 21, 2016
Date of Event
October 11, 2015
Report Date
December 30, 2015
Manufacturer
ELIXIR CORPORATION
Product Code
FRN
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
OH, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE SYRINGE PUMP ALARMED FOR VOLUME DELIVERED. FOUND THE SYRINGE WAS NOT ENGAGED INTO THE PINCH CLAMP AND PUMP WAS RUNNING AS IF DELIVERING THE FEEDING. NO FEEDING WAS DELIVERED. ENTIRE FEEDING WAS LEFT IN THE SYRINGE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
42535 ATLANTA BIOMEDICAL CORPORATION (ABC) INFUSION PUMP PUMP, INFUSION FRN ELIXIR CORPORATION 4100

Patients

Seq Age Sex Outcome Treatment
1 0 YR