MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM 2400, MAIN MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number EM2400

Device Problem Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: the events occurred unknown dates in 2022, reported as ¿over the last six months.¿ should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that particle excursions occurred with two (2) exactamix 2400 compounders.This was observed while reviewing data in which particle counts were found exceeding over time.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The devices were not returned and the serial numbers are unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM 2400, MAIN MODULE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): PLEXUS CORPORATION; 2500 millbrook drive; buffalo grove IL 60089
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15322201
• MDR Text Key: 302493910
• Report Number: 1416980-2022-04520
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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: EM2400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 10/21/2022
• Supplement Dates FDA Received: 11/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1