MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2C8537

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 09/21/2021

Event Type  malfunction  

Event Description

Patient was receiving iv therapy in our infusion center.When the infusion was almost finished, nursing staff noticed that the patients clothing was very wet.On inspection of the infusion set, it was noted that there was fluid leaking from one of the ports of the infusion set.Fda safety report id # (b)(4).

• Brand Name: CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL 60015
• MDR Report Key: 12540102
• MDR Text Key: 273797693
• Report Number: MW5104227
• Device Sequence Number: 1
• Product Code: FPA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2C8537
• Device Catalogue Number: 2C8537
• Was Device Available for Evaluation?: Yes
• 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: 86 YR
• Patient Weight: 68