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

Catalog Number 2C8750

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

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

Event Date 10/10/2021

Event Type  malfunction  

Event Description

It was reported that a clearlink system y-type blood/solution set was defective and leaked platelets onto the floor.The issue was identified during patient infusion.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The user facility submitted medwatch (b)(4) for this event.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed with no leak noted in the set.The reported condition was not verified.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 ; 2242702068
• MDR Report Key: 12751682
• MDR Text Key: 282606528
• Report Number: 1416980-2021-06604
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412046341
• UDI-Public: (01)00085412046341
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K993120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

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 Catalogue Number: 2C8750
• Device Lot Number: DR21C19031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/04/2021
• Supplement Dates Manufacturer Received: 11/30/2021
• Supplement Dates FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2021
• 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