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

Catalog Number 2400M

Device Problem Device Emits Odor (1425)

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

Event Date 04/29/2022

Event Type  malfunction  

Event Description

It was reported that em 2400, main module automated compounding device (acd) smelled like burning.This issue was identified during setup.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction made to g1: baxter healthcare - englewood 14445 grasslands dr englewood co.80112 (previously submitted as plexus corporation 2500 millbrook drive buffalo grove, il.60089).H10: the actual device was received for evaluation.Visual inspection was performed and the top plate was observed scratched, the main module cover was stained and had corroded paint, and a scratched pump cover and worn rubber feet was observed.Unknown fluids were found on the unit.Functional tests including electrical safety and functional system level tests were performed and no issues were noted.During inspection of the power supply, burnt traces were identified on the power supply board (pcb) around components u4, u8 and capacitor c27 from fluid ingress.The reported condition was verified.The cause of the burning odor was due to the damaged power supply board, however the cause of the damage could not be determined.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.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 ; 2242702068
• MDR Report Key: 14501803
• MDR Text Key: 292695575
• Report Number: 1416980-2022-02646
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• 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: 05/18/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1