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

Catalog Number	4C8723
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem 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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Correction: b4/f8: date of this report in mdr follow up #1 is being corrected from blank to (b)(6) 2021.

• Brand Name: CLEARLINK BLOOD RECIPIENT SET
• Common Device Name: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11269427
• Report Number: 1416980-2021-00353
• Device Sequence Number: 3302734
• Product Code: BRZ
• UDI-Device Identifier: 00085412049076
• UDI-Public: (01)00085412049076
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K993120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 4C8723
• Device Lot Number: R19D24100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 03/04/2021; 07/01/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/09/2021; 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.