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

Catalog Number 2400M

Device Problem Break (1069)

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

Event Date 11/14/2022

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 a em 2400, main module door was damaged.Additionally, the "machine crashes" when a product is added.There was no patient involvement.No additional information is available.

Manufacturer Narrative

B3: the date of the event was reported as (b)(6) 2022.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): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 15965600
• MDR Text Key: 306154776
• Report Number: 1416980-2022-06817
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 00085412482637
• UDI-Public: (01)00085412482637
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

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: 2400M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 12/13/2022
• 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