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

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

Patient Problem Hyperglycemia (1905)

Event Date 08/22/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported a neonate patient experienced hyperglycemia after receiving an intravenous infusion of total parenteral nutrition (tpn).The tpn order was created using an exactamix automated compounder device.It was further reported two hours after administration of the tpn, the nurse observed the patient ¿blood glucose levels were high, in the 500 range¿.The tpn was removed and ¿a starter tpn¿ was administered.The glucose levels returned ¿back to normal¿ by the next day.At the time of this report, the patient was in stable condition.No additional information is available.

Manufacturer Narrative

The device was not returned, and the serial 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: NI
• 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: 15462847
• MDR Text Key: 300366257
• Report Number: 1416980-2022-04969
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 10/21/2022
• Supplement Dates FDA Received: 10/24/2022
• 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
• Treatment: 3RD PARTY SOFTWARE FOR TPN ORDER ENTRY; TOTAL PARENTERAL NUTRITION
• Patient Outcome(s): Required Intervention
• Patient Age: 2 DA