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

Catalog Number 2C6750H

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that blood was leaking coming from an unspecified location of an interlink y-type blood set.This was identified when opening the roller clamp.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information d4, g1, h3, h6.D4: catalogue # 2c6750 replaced with 2c6750h.G1 (update to manufacturing location, remove baxter healthcare aibonito reported on initial).H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed to the photograph using the naked eye and the missing roller clamp reported by the customer was observed.No leaks were observed in the picture.Due to the nature of the sample, no additional testing could be performed.The reported condition of missing roller clamp was verified, however, no leak could be verified by the photograph.The cause of the missing roller clamp component was determined to be due to a manufacturing related issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10765393
• MDR Text Key: 214112888
• Report Number: 1416980-2020-06758
• Device Sequence Number: 1
• Product Code: BRZ
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C6750H
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1