MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION DUO-VENT SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	1C8507
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during patient infusion of epoprostenol with a duo-vent solution set, a small hole in the tubing was observed.It was further reported blood backed up into the tubing and the patient became ¿hypotensive and short of breath¿.Phenylephrine was administered ¿to support the blood pressure¿ and the extra-corporeal membrane oxygenation settings were "increased to support the patient".According to the reporter, ¿no apparent force was applied to the tubing; this appeared to happen spontaneously".At the time of this report, the patient outcome was not reported.No additional information is available.
Additional Manufacturer Narrative
The user facility submitted medwatch (b)(4) for this event.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Initially, the cause of the condition was determined to be due to a user handling situation, as it was determined that the reported condition cannot be generated by manufacturing process.However, the cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspection was performed using the naked eye and it was observed that all components were in place; however, a cut in the tube was observed.The set was dimensional measured, and no defects were found.A pull test was performed to all joints of the set and no defects were noted.Leak testing was performed, and a leak from the cut in the tubing was observed.The reported condition was verified.The cause of the condition was determined to be due to a user handling situation, as it was determined that the reported condition cannot be generated by 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: DUO-VENT SOLUTION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15587050
• Report Number: 1416980-2022-05446
• Device Sequence Number: 17936719
• Product Code: FPA
• UDI-Device Identifier: 00085412014319
• UDI-Public: (01)00085412014319
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K203609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2022

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: 03/10/2024
• Device Catalogue Number: 1C8507
• Device Lot Number: DR22C09055
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 11/07/2022; 11/10/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/08/2022; 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• 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: EPOPROSTENOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown