MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM2400 DY V1.14 DISPLAY; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number EXACTA24DY

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/27/2023

Event Type  malfunction  

Event Description

It was reported that particulate matter (pm) contamination was observed within two (2) unspecified bags after compounding using an automated compounding device (acd).The pm was further described as yellow spongy particulate matter which dissolved or dissipated in a few minutes.This was observed upon delivery after the bags were compounded prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction/additional information: serial no.Lot #, e1: initial reporter address.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 DY V1.14 DISPLAY
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ECM - PLEXUS - SP009976; 2400 & 2500 millbrook dr; buffalo grove IL 60089
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16610276
• MDR Text Key: 312019038
• Report Number: 1416980-2023-01312
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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,Followup
• Report Date: 10/18/2023

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: EXACTA24DY
• Device Lot Number: 452446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 10/18/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1