MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX 2400 COMPOUNDER; EM2400

Device Problems Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913)

Patient Problem Underdose (2542)

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014, baxter healthcare (b)(6) technical support was informed by the customer that they are still having an issue with dextrose under delivering on one of their compounders, and stated that they are "tired of throwing away bags, so made clinical decision to send these bags to patients" and acknowledged the potential risk to the customer(s).The customers take these bags home and infuse with a cadd prism infusor pump, and the bags are running dry, since the dextrose is underweight.This mdr has been opened due to the possibility that an under delivery of dextrose could lead to a hypoglycemic patient event where medical intervention may be required and may lead to permanent damage.

Manufacturer Narrative

This report details an incident involving the em2400 exactamix compounder.The em2400 compounder is an automated compounding device (acd) that streamlines multi-source mixing applications for pharmacies.Our investigation has shown that the customer had been working with baxter healthcare (b)(6) technical support regarding an issue with dextrose under delivering on one of the customer's compounders (the customer had called technical support on (b)(6) 2014 and (b)(6) 2014).On (b)(6) 2014, the customer informed technical support that they are still having an issue with dextrose under delivering on one of their compounders, and stated that they are "tired of throwing away bags, so made clinical decision to send these bags to patients" and acknowledged the potential risk to the customer(s).The customer reported that their customers take these bags home and infuse with a cadd prism infusor pump, and the bags are running dry, since the dextrose is underweight.The customer has not reported any adverse effects or medical intervention being required due the bags running dry; however, this mdr has been submitted due to the possibility that an under delivery of dextrose could lead to a hypoglycemic patient event where medical intervention may be required and may lead to permanent damage.The compounder is operating as designed, alerting the customer to the under delivery of an ingredient, and although baxter trains the user to discard any bags that are out of the specified +/- (b)(6) range, the customer used their clinical decision to accept the bags and send them to their customer(s).(b)(4).

• Brand Name: EXACTAMIX 2400 COMPOUNDER
• Type of Device: EM2400
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; 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 ; 3033909757
• MDR Report Key: 4224488
• MDR Text Key: 5000514
• Report Number: 1419106-2014-00015
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1