MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTA-MIX 2400 COMPOUNDING SYSTEM; SYSTEM / DEVICE, PHARMACY COMPOUNDING

Model Number EM2400

Device Problems Contamination (1120); Corroded (1131); Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2022

Event Type  malfunction  

Event Description

Exacta-mix 2400 compounding system, cleaned according to usp(united states pharmacopeia) standards and manufacturer guidelines, was found to have corrosion on the stainless steel vial rack of the fda 510k approved devices (k002705) due to a defect in manufacturer design.The corrosion led to a voluntary recall, as the vial rack resides in the iso(international standards organization) 5 primary engineering control, and in the direct path of first air reaching critical sites on sterile medication ingredients.The manufacturer design was identified by a metal stripping company that evaluated the vial racks and determined that the stainless steel utilized is a 306 grade stainless steel, not a 316 or 320 grade resistant to corrosion.The corrosion is a result of bimetallic corrosion, due to the stainless steel of the rods coming in contact with aluminum of the vial rack connections and the clips used for the vials.When these two metals come together in the presence of a corrosive cleaning agent such as quaternary ammoniums, it leads to corrosion due to the design of the vial rack.The corrosion was confirmed as it was examined under a microscope for evaluation.According to fda guidance document, insanitary conditions at compounding facilities guidance for industry (docket number: (b)(4) section iii.A.1, foreign matter in the production area (ie.Rust) is considered insanitary and subject to fda 483 observations.The design of the 510k device, along with cleaning guidelines within usp standards and manufacturer recommendations, leads to an increased risk of insanitary conditions that may impact the sterility of compounded admixtures.

• Brand Name: EXACTA-MIX 2400 COMPOUNDING SYSTEM
• Type of Device: SYSTEM / DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 16454185
• MDR Text Key: 310586206
• Report Number: MW5115293
• 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: 02/23/2023

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
• Device Model Number: EM2400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1