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

Catalog Number	2C8720
Medical Device Problem Codes	Backflow (1064); Filling Problem (1233)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Device manufacturer address 1: (b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was backflow of transfusion blood while using a clearlink system y-type blood/solution set.This was further described as "while infusing blood the roller clamps on the y-tube failed allowing the backflow of the blood into the 0.9% ns (normal saline) bag as well as allowing 0.9% ns to leak into the blood administration increasing the total volume of infused fluid." this issue was identified during a patient blood infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: the actual sample was received for evaluation.Visual inspection was performed using the naked eye which did not identify any abnormalities that could have contributed to the reported conditions.All components were correctly placed and according to specifications.Functional testing was performed including priming test, clear passage and pressure testing; and no issues were observed; however, a cut was observed on the tubing.The reported backflow issue could not be verified.The cause of the cut was due to a manufacturing process related issue; a potential root cause was determined as an incorrect tubing placement as part of the coiling operation, leading the packaging machine to cut the tubing.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
• Common Device Name: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 13446582
• Report Number: 1416980-2022-00326
• Device Sequence Number: 19909611
• Product Code: BRZ
• UDI-Device Identifier: 00085412049083
• UDI-Public: (01)00085412049083
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K993120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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: Other
• Device Catalogue Number: 2C8720
• Device Lot Number: R21G19059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.9% SODIUM CHLORIDE (NACL).; BLOOD UNIT
• Patient Sex: Unknown