MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE EM 2400, DISPLAY MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number EXACTA24DY

Device Problems Improper or Incorrect Procedure or Method (2017); Inaccurate Information (4051)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the display of an exactamix automated compounding device had misused lipid products.Customer stated "the compounder had been set up incorrectly and their technicians applied the smof lipid barcode labels to their intralipid containers.This caused the compounder to deliver intralipid in place of smof lipid during formula runs".The issue had occurred during compounding; however, it was reported there was patient involvement.Therefore, the bag was infused to a patient.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: it was reported the customer misused the lipid products by setting up the device incorrectly.The technicians applied the smof lipid barcode labels to their intralipid containers.Use errors and proper user instructions are addressed in ¿extamix operator manual¿, which is included with every extamix device.The guide instructs the user to make sure the user labels the inlet with the appropriate, numbered bar code label that was packaged with the valve set.It also tells the user to check that the correct inlet is attached to the correct ingredient and port, as well as, labeled with the correct bar code label.A review of the label for the product family will be conducted.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM 2400, DISPLAY MODULE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE ¿ ROUND LAKE; round lake IL
• Manufacturer (Section G): BAXTER HEALTHCARE - ROUND LAKE; 2575 university ave w; round lake IL 60073
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9147687
• MDR Text Key: 161222474
• Report Number: 1416980-2019-05391
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: EXACTA24DY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1