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

Catalog Number 2C8720

Device Problems Melted (1385); Material Twisted/Bent (2981); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This event occurred on an unspecified date between (b)(6) 2020.Lot # - r19j14034 or r18e28067.(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was no flow through a clearlink system y-type blood/solution set.At the time of this event, the patient was receiving a blood transfusion when the y tubing began twisting and kinking which resulted in the no flow.The healthcare professional attempted to straighten the tubing with no success as the tubing continued to twist due to the tubing being malformed (described as melted).To resolve the issue, the set was replaced, and the transfusion was able to continue successfully.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: the potential lot r19j14034 was manufactured on october 14, 2019.H4: the potential lot r18e28067 was manufactured on may 29, 2018.H10: 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: 10240222
• MDR Text Key: 197914672
• Report Number: 1416980-2020-03805
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

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: 2C8720
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1