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

Catalog Number 2C8750

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The date of the event was reported as an unknown date in (b)(6) 2020.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.It was further reported "the blood product tubing leaked at the bottom of the filter chamber.The outer plastic ring was not sealed".The device was filled with blood platelets.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction: f2 and g3.F2: the user facility submitted a medwatch report for this event: 2400100000-2020-8028.G3: remove consumer (from follow up # 1) and replace with user facility.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information was added to h6.H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.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
• MDR Report Key: 9973778
• MDR Text Key: 188081574
• Report Number: 1416980-2020-02239
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• PMA/PMN Number: K993120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• 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
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1