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

Catalog Number 2C8750

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

Patient Problem No Patient Involvement (2645)

Event Date 03/31/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of a clearlink system y-type blood/solution set separated from the drip chamber which resulted in a leak.It was further reported that when the set was attached to a normal saline bag the leak was observed from the bottom of the drip chamber where the filter is located.This issue occurred during setup and preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction: b3, e1 initial reporter last name.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.

• Brand Name: CLEARLINK BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9998067
• MDR Text Key: 188986572
• Report Number: 1416980-2020-02362
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412046341
• UDI-Public: (01)00085412046341
• 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
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

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 Catalogue Number: 2C8750
• Device Lot Number: DR19J09067
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 05/11/2020
• Supplement Dates FDA Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1