MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK; SET, BLOOD TRANSFUSION

Model Number 2C8750

Device Problems Backflow (1064); Device Difficult to Setup or Prepare (1487); Incomplete or Inadequate Priming (4041)

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

Event Date 11/16/2021

Event Type  malfunction  

Event Description

Two rns went prime blood tubing for rbc administration.When priming the bag, the blood started to back prime through to the other end of the tubing even through the tubing was clamped.In an attempt to stop the blood from leaking, this rn closed all the clamps on the line.Despite doing this, the blood continued to back flow from the opposite end and this rn had to get new tubing.Because of this event there was a small amount of donated blood lost that could have been given to the patient.

• Brand Name: CLEARLINK
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 12959965
• MDR Text Key: 281916886
• Report Number: 12959965
• Device Sequence Number: 1
• Product Code: BRZ
• 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: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2C8750
• Device Catalogue Number: 2C8750
• Device Lot Number: DR21B24116
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other