MAUDE Adverse Event Report: ELITE BIOMEDICAL SOLUTIONS LLC. ELITE BIOMEDICAL BEZEL ASSEMBLY PUMP; ACCESSORIES, PUMP, INFUSION

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

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.

• Brand Name: ELITE BIOMEDICAL BEZEL ASSEMBLY PUMP
• Type of Device: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): ELITE BIOMEDICAL SOLUTIONS LLC.; cincinnati OH 45245
• MDR Report Key: 16436598
• MDR Text Key: 310331041
• Report Number: MW5115145
• Device Sequence Number: 1
• Product Code: MRZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1