MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2R8858

Patient Problem Chemical Exposure (2570)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

Order for pembrolizumab (keytruda) was being compounded.During iv tubing attachment in iv hood, i noticed liquid on the base of the work space.Drug had not been injected yet.There was a leak at one of the points on the tubing with the white plastic covering.Iv pump set clearlink pump 1 port 10 drops / ml drip rate 0.2 micron filter 107 inch tubing chemotherapy medication.No staff or patient harm reported.

• Brand Name: CLEARLINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 25212 w. il route 120; rlt-10; round lake IL 60073
• MDR Report Key: 18484040
• MDR Text Key: 332556655
• Report Number: 18484040
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2R8858
• Device Catalogue Number: 2R8858
• Device Lot Number: R23D24024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2023
• Date Report to Manufacturer: 01/10/2024
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1