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

Model Number 1C8507

Device Problems Backflow (1064); Material Puncture/Hole (1504)

Patient Problems Low Blood Pressure/ Hypotension (1914); Respiratory Insufficiency (4462)

Event Date 07/25/2022

Event Type  malfunction  

Event Description

Iv tubing infusing epoprostenol had a small hole form in the iv tubing.Blood backed up into the tubing.Patient became hypotensive and short of breath.Required intervention with phenylephrine to support blood pressure (before source of the issue was identified), and ecmo settings were increased to support the patient.No apparent force was applied to the tubing; this appeared to happen spontaneously.Iv tubing was baxter "solution set with duo-vent spike".Iv tubing was saved for inspection.

• Brand Name: DUO-VENT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15437193
• MDR Text Key: 300079037
• Report Number: 15437193
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1C8507
• Device Catalogue Number: 1C8507
• Device Lot Number: DR22C09055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1