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

Catalog Number 2400M

Device Problem Microbial Contamination of Device (2303)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the main module of an exacta mix automated compounding device was contaminated; further described as microbial growth.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed which noted the device had a stained bag pan.There was considerable dried, spilled ingredient or cleaning solution oxidation (green) stains on the bottom of main housing copper coating.Functional and electrical testing was performed with no issues noted.The reported issue of microbial growth was not verified; however, a stained bag pan/oxidation of the housing was verified.The cause of the staining/oxidation could not be determined; however, is most likely due to ingredient spills or cleaning solutions, normal wear and tear of unit being in use, or customer not keeping unit clean and dry.The staining/oxidation is not likely to cause harm as this occurred outside of the fluid path.The main module housing cover will be replaced to correct the reported issue.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
• MDR Report Key: 11608246
• MDR Text Key: 246114951
• Report Number: 1416980-2021-01829
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

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: 2400M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 04/02/2021
• Supplement Dates Manufacturer Received: 04/12/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1