MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/CONTINU-FLO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2R8546

Device Problems Fluid/Blood Leak (1250); Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/11/2023

Event Type  malfunction  

Event Description

Rn doing line audits noted iv fluid line leaking from infusion port.Off hour tpn ordered, lipids held, and iv tubing line changed.Manufacturer response for iv tubing, (brand not provided) (per site reporter) baxter has implemented corrective action plans in their manufacturing line and are isolating new product of the corrected product to send directly to ynhhs.

• Brand Name: CLEARLINK/CONTINU-FLO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16609913
• MDR Text Key: 311950100
• Report Number: 16609913
• 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: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2R8546
• Device Catalogue Number: 2R8546
• Device Lot Number: UNKNOWN
• 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: 03/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1