MAUDE Adverse Event Report: BAXA / BAXTER HEALTHCARE CORPORATION BAXA EXACTAMIX 2400 COMPOUNDER VALVE SET; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Device Problems Leak/Splash (1354); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 04/19/2022

Event Type  malfunction  

Event Description

Pharmacist noticed compounded dextrose 50% and some tpns that should be clear were slightly cloudy.Tpns were decided to be appropriate for use after review with the director.The dextrose bags were rerun after multiple attempts of flushing and re-priming ports on compounder.Investigation the following day found that reports to fda existed with consumers/institutions having same issues with baxa exactamix 2400 compounder valve sets having leakage and trace amounts of lipids leaking into non-lipid containing tpns.Lot numbers were listed and reviewed and most reports were since mid march 2022 but our current lot number was not listed.Link to website (https://maude.Innolitics.Com/productcodes/nep?keyword=baxter%20em2400 ) where reports were listed was emailed to director of pharmacy.Baxa was called and they did not list this as a problem but stated that our valve on our compounder maybe going bad.They advised us to move our lipids to a different port which we did.This lead to multiple failures/issues on our compounder leading to the swap of the pump portion of the compounder with the backup pump.Tpns and dextrose on (b)(6) 2022 were crystal clear having been run on new compounder.Fda safety report id# (b)(4).

• Brand Name: BAXA EXACTAMIX 2400 COMPOUNDER VALVE SET
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXA / BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 14695221
• MDR Text Key: 294159594
• Report Number: MW5110310
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 01 DA
• Patient Ethnicity: Non Hispanic
• Patient Race: White