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

Model Number 2R8480

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2022

Event Type  malfunction  

Event Description

Leakage from y-site port above pump.Manufacturer response for iv tubing, non-dehp (per site reporter) initial meeting with baxter on 3/4, requested follow up meeting on 3/31 due to sharp increase in leaks.

• 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: 13994271
• MDR Text Key: 288490904
• Report Number: 13994271
• 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: 03/31/2022

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: 2R8480
• Device Catalogue Number: 2R8480
• Device Lot Number: R21D07085
• 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: 03/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1