MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LINE ACCESSORIES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number	101354
Medical Device Problem Codes	Break (1069); Air/Gas in Device (4062)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient underwent continuous renal replacement therapy (crrt) using a filter set and a y connector.It was further reported that while attempting to return blood and start a normal saline recirculation, the device ¿malfunctioned¿ and as a result, the extracorporeal (ec) blood was not returned.According to the reporter, a second y connector was obtained, however, it was noticed to be broken at the connection hub.A third y connector was reported to be needed, however, too much air had entered the circuit due to the broken y-connector, and treatment was terminated without the ec blood returning to the patient.The patient received a blood transfusion later in the shift.No additional information is available.
Additional Manufacturer Narrative
Additional information: h3, h4, h6 and h10.H4: the devices were manufactured on an unspecified date in june 2021.H10: the actual device was not available; however, a retained sample was evaluated.A review of retention samples confirmed that the units met specifications.The device was not received for evaluation; therefore, a device analysis could not be completed.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: LINE ACCESSORIES
• Common Device Name: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - TUNISIA; route de chebbaou; 2021oued e; tunis ; TS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18369771
• Report Number: 1416980-2023-06674
• Device Sequence Number: 7807030
• Product Code: FJK
• UDI-Device Identifier: 07332414004699
• UDI-Public: (01)07332414004699
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K801016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 101354
• Device Lot Number: 21F18T761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/28/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: NI.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown