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

Catalog Number H938724

Device Problems Contamination (1120); Fluid/Blood Leak (1250)

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

Event Date 03/30/2022

Event Type  malfunction  

Event Description

Faulty valve sets are allowing the leakage of unintended ingredients into iv nutrition bags on the automated compounder.This is particularly occurring with lipids leaking into bags which should not contain lipids.This is a known, recurring issue but it is unknown how widespread this is, or which specific lots are not impacted.Fda safety report id# (b)(4).

• Brand Name: BAXTER EM2400 VALVE SET
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 14021393
• MDR Text Key: 288833302
• Report Number: MW5108776
• 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: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H938724
• Device Lot Number: 60352087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1