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

Model Number 2400-M

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation as there was no indication of device failure.However, the customer did provide baxter with the mixcheck report (the mix check report reports information regarding the completed bag including the expected bag weight, measured bag weight, ordered ingredients and volumes, manual additions that are required for the specific order, and any error encountered during the pumping of the bag) and the device's event log, both of which confirmed the device appropriately alerted the user, with occlusion alarms, to possible flow issues.Additionally, the mixcheck report confirmed the bag was approved for release despite the occlusion alarms being present on the report.Baxter technical support informed the customer of the manufacturer recommendation to discard bags that receive occlusion alarms during production.

Event Description

While troubleshooting a report of a possible under delivery of nacl in a tpn bag produced with an exactamix em2400 compounder, baxter technical support discovered that the user had received occlusion alarms during the production of the tpn bag but did not discard the bag per manufacturer recommendations.Instead, the tpn bag was released and administered to a patient.Occlusion alarms can indicate improper solution flow during compounding, which can result in under-delivery of ingredients.There was no patient injury, adverse event, or medical intervention necessary in relation to this event.No additional information is available.

• 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: 5236588
• MDR Text Key: 31619623
• Report Number: 1419106-2015-00294
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2015

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-M
• 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: 10/21/2015
• Initial Date FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 31 YR
• Patient Weight: 77