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

Model Number 2400-M

Device Problems Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was not returned for evaluation since set-up troubleshooting steps provided by baxter technical support resolved the issue.Additionally, a serial number was not provided; therefore, neither a service history nor a manufacturing review could be performed.The customer report revealed the compounder had issued a warning concerning overweight dextrose 70%, and the mix check 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) indicated that the dextrose may have over delivered by 9.7 g.However, the bag had been approved for release despite this warning.If additional, relevant information becomes available, a follow up report will be submitted.

Event Description

It was reported that a tpn bag, produced using an exactamix compounder, was out of range, with the bag possibly having dextrose 70% overweight by 9.70g (96g of dextrose was ordered).The customer also reported that the compounder had issued an error message that the dextrose 70% was possibly overweight.This bag was authorized for release by the pharmacist and infused into a patient.However, no patient injury, adverse event, or need for medical intervention was reported.Baxter technical support provided the customer with troubleshooting steps to ensure the compounder had been properly set up and subsequent bags produced were within specified range.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: 5100129
• MDR Text Key: 26613147
• Report Number: 1419106-2015-00275
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 09/23/2015

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: Not provided
• Initial Date FDA Received: 09/24/2015
• 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