MAUDE Adverse Event Report: BAXTER HEALTHCARE EM2400 REPLACEMENT DISPLAY (2400-DYR)

Model Number 2400DYR

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

Weight: (b)(6).The device was not returned for an evaluation.However, the customer was able to provide copies of the blackbox data, which provided details about the compounding process and event(s) for the orders.A review of the blackbox data showed the ingredient na acetate was physically switched out and replaced with k acetate, and there was no indication the compounder contributed to this event.Based on the customer report, the cause of this event was determined to be user error.Additionally, a manufacturing review was performed and found no nonconformances in relation to the manufacturing of this device.To avoid configuration confusion, the exactamix operator manual instructs the user to work from left to right in the sequence of the port numbers: by touching the ingredient button on the screen and checking the port number is correct; then attach the inlet to the port; spike and hang the container and label the inlet with the numbered bar code label.This event is logged under complaint file number-(b)(4).

Event Description

The customer called to report that two vials of k acetate were discovered hung on the exactamix compounder, instead of one vial of na acetate and k acetate.One tpn bag was compounded with this configuration and infused to a patient.There was no report of patient injury, adverse event or medical intervention needed.No additional information is available at this time.

• Brand Name: EM2400 REPLACEMENT DISPLAY (2400-DYR)
• Type of Device: EM2400 REPLACEMENT DISPLAY (2400-DYR)
• Manufacturer (Section D): BAXTER HEALTHCARE; 14445 grasslands drive; englewood CO 80112
• Manufacturer (Section G): BAXTER HEALTHCARE; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: phone vang ; 9540 s maroon circle; # 400; englewood, CO 80112 ; 3037846639
• MDR Report Key: 5257358
• MDR Text Key: 32378035
• Report Number: 1419106-2015-00324
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 12/01/2015

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: 2400DYR
• Device Catalogue Number: 2400DYR
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2015
• Initial Date FDA Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2013
• 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: 4 DA