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

Catalog Number 4H8723

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).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 disconnected at the nearest port to the hub.This issue was identified during unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information : the actual sample was received for evaluation.Visual inspection performed using the naked eye did not identify any abnormalities that could have contributed to the reported condition.A functional testing was performed including pressure testing and clear passage testing and no issues noted.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

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: 9695377
• MDR Text Key: 178624645
• Report Number: 1416980-2020-00587
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2020

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: Other
• Device Catalogue Number: 4H8723
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 02/27/2020; 04/27/2020
• Supplement Dates FDA Received: 03/12/2020; 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1