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

Model Number 2R8480

Device Problems Fluid/Blood Leak (1250); Priming Problem (4040)

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

Event Date 11/08/2022

Event Type  malfunction  

Event Description

Technician priming bag prior to adding chemotherapy, noticed that tubing was leaking at the bottom of the chamber where the tubing connects.Lot# (10)r22f14086.Tubing leaking, removed from bag and set aside for evaluation.

• 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: 16042200
• MDR Text Key: 306071108
• Report Number: 16042200
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2R8480
• Device Catalogue Number: 2R8480
• Device Lot Number: R22F14086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/23/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1