MAUDE Adverse Event Report: BAXTER ABACUS TPN SOFTWARE

Device Problems Application Program Problem (2880); Patient Data Problem (3197); Application Program Problem: Medication Error (3198)

Patient Problem No Information (3190)

Event Date 06/08/2016

Event Type  Other  

Event Description

(b)(6) pts (26 pediatric, 21 adult) received x 4 magnesium sulfate doses compounded in their tpn because of a new diluted magnesium sulfate file added to our baxter abacus tpn software unintended to go live but was created for initial testing.The diluted file was created on (b)(6), and the compound used that file for 24 hr tpn bags pumped on (b)(6) resulting in x 4 doses above orders.The software allowed the same ndc to be entered for the current mag sulfate file as well as the new diluted mag sulfate file.The software also defaults to have the "unavailable" option box unchecked.The pharmacist adding the new file did not realize that this boxed needed to be checked to prevent the file from potentially going live.We in contact with baxter regarding the event.We have also contacted (b)(4) to report the event and forwarded software screenshots.

• Brand Name: ABACUS TPN SOFTWARE
• Type of Device: ABACUS TPN SOFTWARE
• Manufacturer (Section D): BAXTER
• MDR Report Key: 5795224
• MDR Text Key: 49782608
• Report Number: MW5063393
• Device Sequence Number: 1
• Product Code: NEP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other