MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2C8419

Device Problems Leak/Splash (1354); Material Integrity Problem (2978)

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

Event Date 03/09/2023

Event Type  malfunction  

Event Description

Baxter clearlink iv tubing primed in pump was infusing for a number of hours, 1.5% saline, while assessing lines, wetness was noted on top of pump and when blue slide clamp was clamped, iv flid was leaking about an inch above the blue clamp.The inside of the pump was wet and some fluid was also on the floor, tube and iv bag saved for inspection.Given to apsm [redacted name], lot# sr22k25020.

• Brand Name: CLEARLINK/DUO-VENT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 17305248
• MDR Text Key: 318847832
• Report Number: 17305248
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2C8419
• Device Catalogue Number: 2C8419
• Device Lot Number: SR22K25020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1