MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM2400 DY V1.13 DISPLAY; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number EXACTA24DY

Device Problem Unexpected Color (4055)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing facility: the device was manufactured at one of the two following locations: (b)(4).The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an exactamix automated compounding device had bright blue fluid in the line.This occurred during set up after priming with folic acid then priming with thiamine.The technical service representative assisted the customer with clearing the line with sterile water; however, blue fluid was still around the rotor.The customer was advised to change tubing, prime micro 6, and double prime dextrose.The customer would finish setting up.There was no patient involvement.No additional information is available.

• Brand Name: EM2400 DY V1.13 DISPLAY
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): SEE H10; see h10; see h10; see h10
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 13047667
• MDR Text Key: 283083431
• Report Number: 1416980-2021-07433
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EXACTA24DY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.