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

Model Number 2400DY

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This issue was resolved through assistance provided by baxter technical support (bts).Based on the customer report and troubleshooting performed by bts, this event was determined to be use error.The exactamix compounder operator manual warns that patient harm may occur if corresponding source container barcodes are not scanned for verification during compounder set-up (i.E.Unattached or unrelated barcodes are scanned).The exactamix compounder operator manual also instructs the user to call bts for any assistance.(b)(4).

Event Description

The customer reported they had intentionally entered trophamine 10% in a tpn order and then hung premasol 10% on the exactamix compounder.During troubleshooting, baxter technical support (bts) discovered the customer had been ordering, within abacus order entry software, trophamine 10% for tpn orders containing premasol 10% and that the exactamix compounder did not have premasol 10% available as a selection.Since the amino acid concentration of 10% is the same for both products, the patient would receive the correct amount of amino acids.However, these two products have different calcium phosphate solubilities.Abacus software provides calcium phosphate solubility curves, based on the product being used, which allows the user to determine the potential for calcium phosphate precipitation in a given tpn order.Entering trophamine 10% but then hanging premasol 10% makes the calcium phosphate solubility curve data incorrect for the product actually being used.The use of incorrect calcium phosphate solubility curve data could lead to precipitation in the finished tpn.The tpn bag prepared with this configuration was released and used on a patient.However, no patient injury or adverse events were reported in relation to this event.Bts helped the customer properly set up premasol 10% in both the exactamix compounder and the abacus software.No additional information is available.Report 9 of 11.

• Brand Name: EM2400 DY DISPLAY (2400-DY)
• Type of Device: EM2400 DY DISPLAY (2400-DY)
• 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: 5488089
• MDR Text Key: 39940600
• Report Number: 1419106-2016-00146
• 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: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2400DY
• Device Catalogue Number: 2400DY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• 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