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

Catalog Number 101354

Device Problems Break (1069); Air/Gas in Device (4062)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/21/2023

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 331047468
• Report Number: 1416980-2023-06674
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414004699
• UDI-Public: (01)07332414004699
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K801016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101354
• Device Lot Number: 21F18T761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Outcome(s): Required Intervention