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

Model Number 2C8750

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink system y-type blood/solution set leaked; the set came apart causing drainage of platelets onto the floor.This was observed while spiking a bag of platelets.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to 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 device was not received for evaluation; 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 - 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: 18112399
• MDR Text Key: 327890123
• Report Number: 1416980-2023-05834
• 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: Non-Healthcare Professional
• 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: Other
• Device Model Number: 2C8750
• Device Catalogue Number: 2C8750
• Device Lot Number: DR23E23017
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 12/08/2023; 05/29/2024
• Supplement Dates FDA Received: 12/18/2023; 05/29/2024
• 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: PLATELET BAG