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

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182)

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

Event Type  No Answer Provided  

Event Description

This report details an incident involving the em2400 exactamix compounder.The exactamix compounder is an automated pumping system that compounds multiple sterile ingredients into a finished solution, and is designed for the preparation of total parenteral nutrition (tpn).The incident detailed below involves tpn therapy bags produced on the em2400 compounder, by our customer, (b)(6) hospital, located in (b)(6).On (b)(6) 2014, the customer called to report that, during the compounding of a tpn bag, dextrose 5% was inadvertently used in place of dextrose 70%.This resulted in a tpn bag with an under delivery of dextrose.One bag was then administered to the patient for 4 hours before the error was caught and the bag was removed.No adverse effects were observed.An under delivery of dextrose could lead to hypoglycemia, and may lead to permanent impairment, if left untreated.

Manufacturer Narrative

On (b)(6) 2014, the customer had called to report hanging an incorrect ingredient on the compounder.On (b)(6) 2014, a follow up email requesting additional information was sent to the customer.On (b)(6) 2014, the end user responded to the follow up email.The customer indicated that they are still trying to determine if the bag was infused to a patient or not.However, during the initial report, the customer did indicate that there was patient involvement and that the incorrect ingredient was hung.The end user did indicate that if there were any additional updates, then they will keep baxter corporate (b)(4) updated.As there was not enough information provided, the patient outcome and bag result(s) are unknown at this time.However, this is an mdr-reportable event due to the nature of the report.No device malfunction was suspected from the information provided from the customer.This was a user-error caused event.Method: actual device not evaluated.Results: none.Conclusions: device operated as specified; the customer admitted to hanging the incorrect ingredient on the compounder.

• Brand Name: EXACTAMIX 2400 COMPOUNDER
• Type of Device: EM2400
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 9540 s maroon circle ste 400; englewood CO 80112
• Manufacturer Contact: phone vang ; 9540 s maroon circle; # 400; englewood, CO 80112 ; 3037846639
• MDR Report Key: 4213468
• MDR Text Key: 21452132
• Report Number: 1419106-2014-00013
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other