MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX® EM2400 COMPOUNDER

Model Number 2400-M

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

This complaint is logged under complaint file number (b)(4).The customer provided the mix check report associated with this event (the mix check report provides information regarding the completed bag, including expected bag weight, actual measured weight, ordered ingredients and volumes, manual additions, and any error encountered during pumping of the bag) as well as a copy of the device event log.Review of the mix check report and event log determined the device operated appropriately and as designed.Based on this review and the customer report, this event was determined to have been caused by use error.The (b)(4) operator manual details the importance of having a cosigner independently verify the setup, to help ensure that the first user attached each ingredient's inlet to the correct port as incorrect setup could result in patient harm.Additionally, the (b)(4) operator manual recommends watching and holding the source container tubing as it is being primed to ensure correct connection and warns that an ingredient must be attached to the proper port as patient harm can occur if the location of an ingredient is incorrect.

Event Description

The facility reported that while setting up the (b)(6) compounder, the connections for the source ingredients dextrose (b)(4) and sterile water were inadvertently switched, causing the dextrose (b)(4) to be connected to the port intended for sterile water and the sterile water to be connected to the port intended for dextrose (b)(4).This resulted in a starter neonatal iv bag that contained higher than intended concentration of dextrose (b)(4).Infusion of the bag was started but later stopped when it was noted the patient's glucose levels had become elevated.However, the patient did not experience an adverse event or injury.Additionally, no medical intervention was performed or necessary to preclude an adverse event or injury.Baxter technical support reviewed the set-up guidance provided in the (b)(6) operator manual with the customer.

• Brand Name: EXACTAMIX® EM2400 COMPOUNDER
• Type of Device: EM2400
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: carl mcneal ; 9540 south maroon circle; suite 400; englewood, CO 80112
• MDR Report Key: 5784461
• MDR Text Key: 49236574
• Report Number: 1419106-2016-00280
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 2400-M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 1.5 MO
• Patient Weight: 2