MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. BAXTER SOLUTION SET WITH DUO-VENT ; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2C8875

Device Problems Fluid/Blood Leak (1250); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2020

Event Type  malfunction  

Event Description

Clearlink system, solution set with duo-vent (item#2c8875) from baxter leaks from the tubing at the white, heat-shrunk plastic connector that connects the tubing; there are 2 on each set.This has happened on 2 separate occasions during antineoplastic compounding, exposing personnel to hazardous drug and rendering the compound non-sterile/contaminated.Fda safety report id# (b)(4).

• Brand Name: BAXTER SOLUTION SET WITH DUO-VENT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORP. ; deerfield IL 60015
• MDR Report Key: 10013165
• MDR Text Key: 189589739
• Report Number: MW5094315
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/27/2020
• 2 Devices were Involved in the Event: 1 2

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: 2C8875
• Device Catalogue Number: 2C8875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 YR