MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP EXACTAMIX 500ML EVA CONTAINER; SET, I.V. FLUID TRANSFER

Model Number H938738

Device Problems Fluid/Blood Leak (1250); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 03/11/2020

Event Type  malfunction  

Event Description

500 ml exactamix eva container has a leak where the pump port meets the container.Technician noted that it was not sealed properly.There were no patient interactions and the product is available for evaluation by baxter if they wised to do so.

• Brand Name: EXACTAMIX 500ML EVA CONTAINER
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORP
• MDR Report Key: 9859896
• MDR Text Key: 184482704
• Report Number: MW5093860
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2020

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: No Information
• Device Expiration Date: 04/30/2022
• Device Model Number: H938738
• Device Catalogue Number: H938738
• Device Lot Number: 6018798
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1