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

Catalog Number 4C8723

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

Patient Problem No Patient Involvement (2645)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Device manufacturer address 1: (b)(4).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 spike.This was identified during priming of a blood bag which resulted in a leak.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4 and h6.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph was performed using the naked eye which observed the tubing was separated from the spike.Due to the nature of the sample, no additional testing could be performed.The reported condition was verified.The cause of the condition could not be determined.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
• MDR Report Key: 11269469
• MDR Text Key: 230468520
• Report Number: 1416980-2021-00352
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412049076
• UDI-Public: (01)00085412049076
• Combination Product (y/n): Y
• 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
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4C8723
• Device Lot Number: R20F22155
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1