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

Lot Number 60187198

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 02/27/2020

Event Type  malfunction  

Event Description

There is a circular core floating in the exactamix 500 ml eva container which i believe resulted from spiking the middle port - over 100 ml of drug has been used for pt doses; not sure by how many nor given to which pts.

• Brand Name: EXACTAMIX 500 ML EVA CONTAINER
• Type of Device: SET, I.V, FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.
• MDR Report Key: 9779934
• MDR Text Key: 182154438
• Report Number: MW5093482
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• 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: 02/28/2020

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 Lot Number: 60187198
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1