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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/12/2022

Event Type  malfunction  

Event Description

Patient was taken to nuclear med.Rn had a fairly full bag of vasopressin before leaving the unit.When they were in the nuclear med area awaiting to be transferred to the table, rn noticed that the bag was almost empty and there was a pool of fluid on the floor from the vasopressin iv line.Leaking was noticed to be in the middle of the line, between the drip chamber and y site.Patient was very unstable, the nurse forgot to save the tubing.Manufacturer response for iv tubing, iv tubing (per site reporter).Ongoing issue with baxter.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15282375
• MDR Text Key: 298489633
• Report Number: 15282375
• 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: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• 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: 08/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1