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

Catalog Number	EXACTA24DY
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the display of an exactamix automated compounding device was contaminated with a microbial growth.The contamination was observed during an unspecified process step prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: d9, h3, h6.Correction to g1 address.H10: the device was received for evaluation.A visual inspection was performed which noted the device had unknown fluids on the display.Functional system level testing was performed with no issues noted.The reported microbial growth was not verified; however, fluids were found on the display.The fluid on the display is outside the fluid path and would not impact the sterility of the solution compounded.The cause of the fluids could not be determined.The display would be serviced and replaced.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM 2400, DISPLAY MODULE
• Common Device Name: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11619501
• Report Number: 1416980-2021-01897
• Device Sequence Number: 19604460
• Product Code: NEP
• UDI-Device Identifier: 00085412609034
• UDI-Public: (01)00085412609034
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Catalogue Number: EXACTA24DY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1