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

Model Number 2C8612

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 12/12/2018

Event Type  malfunction  

Event Description

Baxter clearlink system extension set tubing came apart where tubing connects to male leur adapter, had to replace with new extension set.

• Brand Name: CLEARLINK SYSTEM EXTENSION SET
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL 60015
• MDR Report Key: 8175458
• MDR Text Key: 130911129
• Report Number: MW5082213
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/13/2018

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: 2C8612
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2018
• 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