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

Model Number 2400-MR

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported they had released tpn bags for patient use after bypassing occlusion errors, which occurred during tpn production on port # 24 of an exactamix® compounder.Bypassing occlusion errors can lead to an under delivery of ingredients.The tpn bags were administered to patients; however, no patient injury, adverse event, or medical intervention was reported by the customer in relation to this event.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation and was visually inspected and functionally tested.Functional testing could not duplicate the reported occlusion errors; however, port # 24 on the compounder failed to consistently open during the testing due to evidence of spilled ingredients.A service history review was performed, finding no relationship between the reported event and previous servicing of the device.Based on the customer report of releasing tpn bags after bypassing occlusion alarms during tpn production, the cause of the reported event was determined to be user error.The exactamix operator manual instructs the user to discard the bag when occlusion alarms occur during production.

• 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 ; 3033909757
• MDR Report Key: 4910654
• MDR Text Key: 6016442
• Report Number: 1419106-2015-00127
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2015

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: Other Health Care Professional
• Device Model Number: 2400-MR
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 73