MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX EM2400 COMPOUNDER

Device Problems Improper or Incorrect Procedure or Method (2017); Application Program Problem: Medication Error (3198)

Patient Problem Death (1802)

Event Type  Death  

Event Description

This report details an incident involving our 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)(4).On (b)(6) 2014, we were contacted by the customer, who requested assistance in providing database files stored within the compounder to the tennessee state board of pharmacy.Initially, the customer was unwilling to share the reasons behind this request until obtaining management approval.On (b)(6) 2014, after receiving approval to disclose further information, the customer informed us of an incident which occurred on, or around, (b)(6) 2014.This incident involved a (b)(6) old patient of a (b)(6) receiving tpn therapy bags containing unintentionally high levels of dextrose.Medical intervention was administered in the form of an insulin drip, and the child was moved to (b)(6).We were informed that the child later died at (b)(6), although the cause of death has not been disclosed at this time.

Manufacturer Narrative

On (b)(4) 2014, the customer contacted our technical support staff requesting the replacement of their em2400 hardware, apparently due to an ingredient delivery issues they had experienced.Specifically, we were told they received error messages concerning the delivery of trophamine 10%.Our tech support personnel instructed the customer on the correct methods for resolving such issues and the case was considered closed.The customer at no time indicated that a patient was in any way involved with this request.On (b)(6) 2014, the customer called back indicating that the tennessee state board of pharmacy wanted access to the device blackbox files for (b)(6) 2014.The customer did not disclose the purpose of this request at that time.On (b)(6) 2014, the (b)(4) office agreed to disclose the purpose of the request, and we were informed of an incident involving a (b)(6) year-old patient receiving an over delivery of dextrose by way of tpn therapy.Medical intervention was conducted through an insulin drip, but the patient was then moved to (b)(6).Although we were informed that the child later died at (b)(6), the cause of death has not been disclosed.Method: (code unspecified).Although the physical device has not been returned, and therefore cannot be examined, the device blackbox files, mixcheck reports and the exactmix database were made available and reviewed as part of the investigation.These reports represent a history of the formulas compounded on the device, including a record of user actions regarding the creation of specifics tpns.Results: no failure detected.The examination of the device history logs and mixcheck reports identified the exact compounding orders for the bags in question.After a thorough review of these records, all initial evidence suggests the user of the device hung a bag of dextrose in place of sterile water.The em2400, recognizing the suspected error, alerted the user of possible concentration delivery issues on multiple occasions; however, these warnings were overridden.Conclusions: user error caused event.This investigation has determined the device was operating within specification, and no device failures have been detected.All evidence suggests user error caused this event.Device not returned.

• Brand Name: EXACTAMIX EM2400 COMPOUNDER
• Type of Device: EM2400
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 9540 s. maroon circle, ste 400; englewood CO 80112
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: eric cops ; 9540 s. maroon circle, ste 400; englewood, CO 80112 ; 3033909774
• MDR Report Key: 4086512
• MDR Text Key: 4743812
• Report Number: 1419106-2014-00008
• 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
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 24 MO