MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. BAXTER EXACTAMIX 2L BAG; SYSTEM / DEVICE, PHARMACY COMPOUNDING

Model Number H938740

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2018

Event Type  malfunction  

Event Description

Exactamix 2l ref h938740, lot 60126015, exp 04/30/2021, leaking during compounding at the center port ridge.

• Brand Name: BAXTER EXACTAMIX 2L BAG
• Type of Device: SYSTEM / DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.
• MDR Report Key: 8196931
• MDR Text Key: 131765393
• Report Number: MW5082583
• Device Sequence Number: 1
• Product Code: NEP
• 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

• Date FDA Received: 12/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Model Number: H938740
• Device Lot Number: 60126015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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