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

Catalog Number 2400-DY

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

Patient Problem Hyperglycemia (1905)

Event Date 02/15/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the dextrose and the sterile water ¿inlets were switched" during the compounding of total parenteral nutrition (tpn) bags with an exactamix automated compounding device.During tpn administration, the neonate patient experienced elevated blood glucose levels.Subsequently, the infusion was stopped mid infusion.The patient was treated with intravenous insulin (2 single doses, no further details).It was reported the patient did not experience any signs or symptoms related to the elevated blood glucose levels.At the time of this report, the patient was recovered from the event.No additional information is available.

Manufacturer Narrative

The device was not received for evaluation; therefore, a device analysis could not be completed; however, the compounder black box data was evaluated.Upon data evaluation, there was no evidence that the compounder or the compounder software contributed to the reported event of the patient receiving the incorrect drugs via switching of the inlets.The data provided showed that the bag produced by this compounder, without any environmental or physical interference, should have been acceptable for clinical use.The device functioned as intended from what was observed from the black box information.The reported condition was not verified.It is possible that the reported event was due to a use error.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM2400 DY DISPLAY
• 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: 9865744
• MDR Text Key: 184473474
• Report Number: 1416980-2020-01627
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2400-DY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DEXTROSE 70%
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA