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

Catalog Number	2C6720
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a y-type blood/solution set leaked in the y-tubing by the filter.This was discovered during patient infusion of bone marrow product.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
G1: device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: the device was received for evaluation.A visual inspection with the naked eye was performed which did not identify any abnormalities that could have contributed to the reported condition.All components were correctly placed and according to specifications.Functional tests which included pressure test and clear passage under water tests were performed and the results were not satisfactory; a leak was observed due to a hole in the center seal of the pump assembly with filter.The reported condition was verified.The cause of the condition was due to a method process variation during the radio frequency sealing at the ends of the product during the manufacturing process.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: INTERLINK 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 60073 ; 2242702068
• MDR Report Key: 17126036
• Report Number: 1416980-2023-02906
• Device Sequence Number: 7387861
• Product Code: BRZ
• UDI-Device Identifier: 00085412004006
• UDI-Public: (01)00085412004006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/13/2023

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: 2C6720
• Device Lot Number: R22J21086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2022
• 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: BONE MARROW PRODUCT.
• Patient Sex: Unknown