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

Catalog Number EXACTA24DY

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

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

Event 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.

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
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11619501
• MDR Text Key: 246800392
• Report Number: 1416980-2021-01897
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 00085412609034
• UDI-Public: (01)00085412609034
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: EXACTA24DY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1