inforMED
MalfunctionMRZ

ELITE BIOMEDICAL BEZEL ASSEMBLY PUMP

Received Feb 23, 2023

Report MW5115145 · MDR key 16436598

Device

Generic name

Accessories, Pump, Infusion

Product problems

  • Excess Flow or Over-Infusion

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT MORPHINE INFUSED OVER FIVE (5) HOURS, HOWEVER WAS ORDERED TO INFUSE OVER TWENTY-FOUR (24) HOURS. THERE WAS NO PATIENT HARM. BD PERFORMED INVESTIGATION, IT WAS FOUND THE ROOT CAUSE OF THE REPORTED OVER INFUSION WAS DETERMINED TO BE DUE TO A THIRD-PARTY BEZEL ASSEMBLY. THE THIRD PART WAS MANUFACTURED BY ELITE BIOMEDICAL. THIRD PARTY PARTS HAVE NOT BEEN VALIDATED BY BD FOR SAFETY AND EFFICACY WITH ALARIS SYSTEM PRODUCTS.