MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM2400 MAIN MODULE COMPOUNDER; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 2400MR

Device Problem Break (1069)

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

Event Date 11/29/2022

Event Type  malfunction  

Event Description

It was reported that the main module door on an automated compounding device (acd) would not close.While changing the tubing set, the pump would not prime, and an error occurred indicating that the pump would not start because the pump door was open.It was observed that one of the magnets was missing; however, the magnet was found, placed back on the door, and the device started to function normally.This event occurred prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was not returned.Therefore; a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM2400 MAIN MODULE COMPOUNDER
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ECM - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16034826
• MDR Text Key: 306445626
• Report Number: 1416980-2022-07012
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2400MR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1