MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. EXACTAMIX 250 ML BAG; SET, I.V. FLUID TRANSFER

Model Number H938737

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 12/14/2018

Event Type  malfunction  

Event Description

Exactamix 250ml leak found from the middle port, discovered during compounding.

• Brand Name: EXACTAMIX 250 ML BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.
• MDR Report Key: 8197209
• MDR Text Key: 131737262
• Report Number: MW5082597
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: H938737
• Device Lot Number: 601307085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/24/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1