MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM2400 MAIN COMPOUNDER MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Model Number 2400-MR

Device Problems Occlusion Within Device (1423); Application Program Problem: Medication Error (3198)

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

Event Date 04/07/2015

Event Type  malfunction  

Event Description

A customer called baxter technical support on (b)(6) 2015 to troubleshoot occlusion alarm errors on the exactamix compounder.During the call, the customer mentioned that the tpn bags she produced the night before triggered occlusion alarms.The alarm was bypassed and the tpn bags were sent to patients.Occlusions were received the night before while pumping vitamin c, potassium phosphate, and mvi pediatric.Technical support provided the customer basic troubleshooting steps to clear occlusion errors and then advised the customer that if the errors persisted, to change the valve set and call technical support again.On (b)(6) 2015, a pharmacist at was contacted.He stated that no patient adverse events have been reported.He also stated that no further occlusion errors have been reported while using the compounder.On (b)(6) 2015 technical support contacted the customer.The facility mentioned that they have implemented corrections on their side to ensure a pharmacist reviews the mix-check reports prior to releasing product to production.A mix-check is a report generated by the compounding device that provides information relative to events that occur during the production of a solution for a patient.This mix-check report lists basic patient and formula information, as well as, miscellaneous system events that occurred during compounding.

Manufacturer Narrative

An investigation was conducted under cfn-(b)(4) for the exacta-mix compounder.The investigation determined that the compounder displayed occlusion error messages as designed; therefore, the device is considered to have operated as intended.No testing methods can be performed and no results are available since the product did not return for an evaluation.As the pharmacy tech admitted that occlusion alarms were given and she bypassed the message, this event has been concluded to be a user error caused or contributed event.Attempts have been made to receive black box files and mix-check reports to further investigate the complaint; however, the customer did not provide this data.Black box data is a feature in the exacta-mix software that stores all system activity.The em2400 operator's manual offers troubleshooting guides for issues with the occlusion detector/"flow sensor".The manual also includes tips on proper techniques to apply in an effort to prevent occlusions.Baxter recommends that anytime an occlusion alarm is given, the tpn bag should be discarded.

• Brand Name: EM2400 MAIN COMPOUNDER MODULE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 14445 grasslands dr; englewood CO 80112 706
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; 14445 grasslands dr; englewood CO 80112 706
• Manufacturer Contact: venessa gatuma ; 9540 south maroon circle; suite 400; englewood, CO 80112 ; 3036904204
• MDR Report Key: 4752095
• MDR Text Key: 5772922
• Report Number: 1419106-2015-00081
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2400-MR
• Device Catalogue Number: 2400MR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2009
• 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