MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC.; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Fluid/Blood Leak (1250); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 02/24/2022

Event Type  malfunction  

Event Description

Patient came from sicu for mri.Iv fentanyl was primed on mri pump.Upon transferring patient into the mri scanner, the pump was alarming, saying bubbles detected, upon inspecting, there was a leak from the line.Patient was given bolus by her nurse while waiting to prime a new line.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 14345555
• MDR Text Key: 291291422
• Report Number: 14345555
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1