MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ONE-LINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	7N8377
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Air Embolism (1697); Chest Pain (1776); Dyspnea (1816); Vertigo (2134); Dizziness (2194)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a one-link non-dehp y-type standard bore catheter extension set separated, and the patient subsequently experienced an air embolism.While undergoing extracorporeal photopheresis the patient began coughing and a spot of blood was observed on their chest.The patient coughed again, and the extension set ¿came apart¿ at the connection between the luer connection and the bifurcation of the pigtails ¿due to the force of coughing¿.When the extension set separated, ¿the port was open to air and with the patient's coughing, air was drawn into the port¿.The patient experienced chest pain, shortness of breath (saturations 80-82% on 6l nasal cannula), dizziness, and lightheadedness.The rapid response team was called to the patient¿s room and an ekg and chest x-ray were performed immediately.The extracorporeal photopheresis procedure was aborted, the one-link had been in use for 110 minutes.The patient was taken to the emergency room and admitted for observation on high flow oxygen.A chest x-ray and ct without contrast were completed (patient unable to undergo ct with contrast or vq scan due to contrast allergy); however, air embolism was diagnosed ¿based on the sequence of events and acute symptoms¿.Two days after the event onset, the patient was discharged from the hospital with follow-up care by their physician.No further information was available at the time of this report.
Additional Manufacturer Narrative
The device was requested.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to d9, e4, h3, h4, h6, and h10.H11: the actual device and photographs of the sample were received for evaluation.The returned photographs were reviewed, and it was noted that the y-junction came apart from the tubing.The actual sample was visually inspected, and it was also noted that the y-junction came apart from the tubing and there was solvent noted.The reported condition was verified.The cause of the reported condition could not be determined; however, was most likely a user-related issue as the customer had reported that ¿extension set came apart at the leur connection due to the force of her coughing and it caused her to have symptoms of air embolism¿.In addition, as per event description the extension set was in use for 110 minutes, meaning that therapy had started with no issue for 110 minutes, and the condition began after the patient coughed.As result, the force applied may have contributed to the issue.A nonconformance has been opened to address this issue.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: ONE-LINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; piisa industrial park antigua; carretera sanchez km 18 1/2; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20776501
• Report Number: 1416980-2024-06798
• Device Sequence Number: 8004851
• Product Code: FPA
• UDI-Device Identifier: 00085412091808
• UDI-Public: (01)00085412091808(10)DR24D08024
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K132734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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 Model Number: 7N8377
• Device Catalogue Number: 7N8377
• Device Lot Number: DR24D08024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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; ANGIODYNAMICS NEEDLE; ANTICOAGULANT CITRATE DEXTROSE SOLUTION; BARD POWER PORT; THERAKOS PHOTOPHERESIS PROCEDURAL INLET
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 62 KG