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

Model Number 4C8723

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that six (6) clearlink system y-type blood/solution sets leaked.This event was further described as, ¿the blood tubing chamber filter at the base point where it ties the tubing had pinhole/leaks¿.This occurred during setup.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h4, h6, and h10.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were discarded; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction/additional information: d1, d3 device manufacturer name, d4: model #, d4: unique identifier (udi) #, g4: combination product.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18194620
• MDR Text Key: 328827562
• Report Number: 1416980-2023-06135
• Device Sequence Number: 1
• Product Code: BRZ
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4C8723
• Device Catalogue Number: 4C8723
• Device Lot Number: R22I24178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 12/17/2023; Not provided
• Supplement Dates FDA Received: 12/21/2023; 05/29/2024
• Date Device Manufactured: 09/27/2022
• 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
• Treatment: NA.