LVP BEZEL ASSY NOEM
Received Mar 5, 2024 · Event occurred Dec 26, 2023
Report MW5152340 · MDR key 18846244
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Elite Biomedical Solutions, Llc.Model number
49000270Lot number
49000270
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN UNSPECIFIED FLUID WAS PROGRAMMED TO INFUSE FOR SEVEN (7) HOURS. HOWEVER, IT WAS COMPLETED IN 40 MINUTES. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. THE MEDICATION INVOLVED WAS PROPOFOL, ORDERED TO INFUSE AT 14.1ML/HR. (30MCG/KG/HR.). PER BD ALARIS MANUFACTURER'S INVESTIGATION: THE ROOT CAUSE OF THE REPORT THAT THE USER PROGRAMMED A SEVEN HOUR INFUSION BUT COMPETED IN FORTY MINUTES WAS DETERMINED TO BE DUE TO USE OF A THIRD-PARTY BEZEL (BEZEL MANUFACTURED BY ELITE BIOMEDICAL SOLUTIONS). THE THIRD-PARTY BEZEL ASSEMBLY INSTALLED WAS A CONTRIBUTING FACTOR TO THE REPORTED OVER INFUSION.