MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK; SET, BLOOD TRANSFUSION

Model Number 2C8750

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

Blood tubing from clearlink y-type blood/solution set leaked from the y-power section below the roller clamp.Looked like a defecting tubing.

• Brand Name: CLEARLINK
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 12982953
• MDR Text Key: 282104799
• Report Number: 12982953
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/29/2021

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 Model Number: 2C8750
• Device Catalogue Number: 2C8750
• Device Lot Number: (10)DR21A28055
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/29/2021
• Date Report to Manufacturer: 12/13/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA