MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK; SET, BLOOD TRANSFUSION

Model Number 2C8750

Device Problems Failure to Disconnect (2541); Component or Accessory Incompatibility (2897); Physical Resistance/Sticking (4012)

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

Event Date 05/22/2023

Event Type  malfunction  

Event Description

Patient received stem cell transfusion with the blood tubing connected directly to the hub of the patient's double lumen hickman catheter.After the stem cell transfusion was completed, the rn caring for patient attempted to disconnect the tubing from the hickman catheter line and was unable to do so due to the tubing breaking.Rn was unable to untwist the tubing and an interventional radiologist came to bedside and was also unable to remove.As a result, the patient had to have an additional procedure to replace the hickman line.

• Brand Name: CLEARLINK
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 17106051
• MDR Text Key: 316957552
• Report Number: 17106051
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2C8750
• Device Catalogue Number: 2C8750
• Device Lot Number: DR23C22048
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2023
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25185 DA
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Race: Asian