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

Catalog Number 2C8750

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Event Description

It was reported that the clamps of a clearlink system y-type blood/solution set were defective.The event was further described as, ¿the two clamps above the blood filter is not as tight as it once was." this resulted in wastage of blood and other products.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the provided photograph did not identify any abnormalities that could have contributed to the reported condition.The reported condition is not clearly observed via the provided photographs.Due to the nature of the sample, no additional testing could be performed.Therefore, the reported condition could not be verified.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: 17757487
• MDR Text Key: 323524544
• Report Number: 1416980-2023-04669
• 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
• Report Date: 10/20/2023

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: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: No
• 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: BLOOD