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

Catalog Number 2400D

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A pediatric patient experienced hyperglycemia when they were infused with "dextrose 3/4%" in an unspecified electrolyte solution due to an operator error by an end user who had incorrectly compounded the solution in the pharmacy.Normal saline was supposed to be used instead of "dextrose 3/4%".There was no defect, damage, or malfunction with the compounding device or any of the components used to compound the solution.As a result the patient who had been on blood glucose monitoring for an unknown indication and was receiving insulin (intravenously), experienced an elevated blood sugar "significantly higher than what it should have been instead of decreasing".The infusion was stopped and the patient was given extra doses of intravenous insulin.The reported issue was resolved.Additional information is not available.

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.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 - ENGLEWOOD; englewood CO
• 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: 6517058
• MDR Text Key: 73556854
• Report Number: 1416980-2017-03586
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2400D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention