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

Catalog Number 2400M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dehydration (1807); Electrolyte Imbalance (2196)

Event Date 07/03/2021

Event Type  Injury  

Manufacturer Narrative

The user facility submitted medwatch (b)(4) for this event.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported a patient receiving total parenteral nutrition (tpn) with an exactamix main compounder module, experienced a sodium increase of 152 meq/l to 158, chloride 116 to 121, and blood urea nitrogen mg/dl 25 to 33, despite lowering the concentration daily in the tpn.It was reported the events occurred after an unspecified pump malfunction (no further details).It was reported the increased sodium could have been from dehydration.The patient received 1/2 normal saline which resulted in stable sodium levels.It was further reported the event required patient monitoring to confirm that it resulted in no patient harm.The patient outcome was reported as "no harm sustained".No additional information is available.

Manufacturer Narrative

The device was not received for evaluation; therefore, a device analysis could not be completed.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: 12598809
• MDR Text Key: 275441370
• Report Number: 1416980-2021-06159
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2400M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR
• Patient Sex: Male