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

Catalog Number 2C8750

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Date 12/28/2023

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of a clearlink system y-type blood/solution set came apart from the connection.This occurred after the nurse spiked the blood bag and unclamped the tubing, during setup/ preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed to the photograph which showed the spike came apart from tubing.The reported condition was verified.Due to the nature of the sample, no additional tests were performed.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18553814
• MDR Text Key: 333379716
• Report Number: 1416980-2024-00117
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412046341
• UDI-Public: (01)00085412046341
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8750
• Device Lot Number: DR23J31048
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1