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

Model Number 2400-DYR

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was not returned for evaluation.A service history review was performed, finding no relationship between the reported event and previous servicing of the device.Based on the review of the mixcheck report, and 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.

Event Description

Baxter technical support received a mix check report (the mix check report reports information including the expected bag weight, measured bag weight, ordered ingredients and volumes, manual additions that are required for that specific order, and any error encountered during the pumping of the bag) from the customer that indicated there was an occlusion error on port # 1 when pumping the tpn.Follow up with the customer confirmed that the bag was delivered to the patient.Bypassing occlusion errors can lead to an under delivery of ingredients.Although the tpn bag was administered to the patient, no patient injury, adverse event, or medical intervention was reported by the customer in relation to this event.

• 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: 5015799
• MDR Text Key: 23529163
• Report Number: 1419106-2015-00176
• 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: company representative,health
• Reporter Occupation: Other
• Report Date: 08/19/2015

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-DYR
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 57