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

Model Number 2R8858

Device Problems Tear, Rip or Hole in Device Packaging (2385); Obstruction of Flow (2423)

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

Event Date 12/27/2019

Event Type  malfunction  

Event Description

It seems some devices have a tear, and some may have a hole.(the hole was introducing air bubbles into the line?).These holes/tear were near the portion of the tubing that goes into the pump chamber.

Event Description

It seems some devices have a tear, and some may have a hole.(the hole was introducing air bubbles into the line?).These holes/tear were near the portion of the tubing that goes into the pump chamber.

• Brand Name: CLEARLINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 10940129
• MDR Text Key: 219334476
• Report Number: 10940129
• 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
• Type of Report: Initial,Followup
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2R8858
• Device Catalogue Number: 2R8858
• Device Lot Number: R18B21036
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1