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

Catalog Number 1C8507

Device Problem Material Puncture/Hole (1504)

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)

Event Date 07/25/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

The user facility submitted medwatch (b)(4) for this event.Should additional relevant information become available, a supplemental report will be submitted.

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.

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
• Type of Device: 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
• MDR Text Key: 301560637
• Report Number: 1416980-2022-05446
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412014319
• UDI-Public: (01)00085412014319
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• 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: EPOPROSTENOL
• Patient Outcome(s): Required Intervention