MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS®; ABACUS® TPN CALCULATION SOFTWARE, PRODUCT CODE: JQP

Model Number 8300-0047

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Infiltration into Tissue (1931)

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014, baxter (b)(4) received a call from (b)(6), requesting assistance in restoring an archived patient from 2012 within their abacus® software, which is used with the baxter em2400 exactamix compounder.The exactamix compounder is an automated pumping system that compounds multiple sterile ingredients into a finished solution, and is designed for the preparation of total parenteral nutrition (tpn).During the discussion, the customer noted that an order was administered peripherally to the patient and it infiltrated and got under the skin.The customer stated that a warm compress was applied to the area.It is unknown at this time if the baxter products contributed to the event; however, we are filing a mdr report because, if repeated, an iv infiltration of a vesicant solution can produce conditions of varying degrees which can lead to injury requiring medical intervention.Should additional information regarding this event become available, a follow-up report will be submitted.

Manufacturer Narrative

Method: no testing methods performed.Results: no results available since no evaluation performed.Conclusions: the customer call was regarding restoring an archived patient within the abacus software.The information regarding a patient involved event was discovered through the conversation with tech support and occured up to two years ago.Should additional information regarding this event become available, a follow-up report will be submitted.

• Brand Name: ABACUS®
• Type of Device: ABACUS® TPN CALCULATION SOFTWARE, PRODUCT CODE: JQP
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 9540 s. maroon circle, ste 400; englewood CO 80112
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: lou fearing ; 9540 s. maroon circle, ste 400; englewood, CO 80112 ; 3037846653
• MDR Report Key: 4367008
• MDR Text Key: 5290514
• Report Number: 1419106-2014-00019
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Pharmacist
• Device Model Number: 8300-0047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1