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

Model Number H9382400-DY

Device Problem Defective Device (2588)

Patient Problem Electrolyte Imbalance (2196)

Event Date 07/03/2021

Event Type  malfunction  

Event Description

Medically complex child admitted for concerns of acute on chronic pancreatitis.Patient nothing by mouth (npo) and total parenteral nutrition (tpn) dependent for nutrition.Patient with ongoing higher sodium and chloride levels; team adjusting na, cl, and k concentration in tpn on daily basis in effort to normalize electrolytes on basic metabolic panel (bmp).Following pump malfunction, patient sodium increased 152 > 158, chloride 116> 121, and bun 25 > 33 despite lower these daily in tpn.Increased sodium could have been from dehydration / started 1/2 normal saline (ns), which is still running / sodium stable.Event required patient monitoring to confirm that it resulted in no patient harm.

• Brand Name: EXACTAMIX
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER CORPORATION ENGLEWOOD; one baxter parkway; deerfield IL 60015
• MDR Report Key: 12438371
• MDR Text Key: 270301929
• Report Number: 12438371
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: H9382400-DY
• Device Catalogue Number: 2400DY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4015 DA