MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number 8300-0046

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2014

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014, baxter (b)(4) was informed of an event that occurred at the (b)(6).The event involved the baxter em2400 exactamix compounder, using abacus® software.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) solutions.The customer stated that after a tpn order had been created and administered to a patient, they realized that the osmolarity level of the solution was higher than expected.The customer did not report any adverse effects to the patient.Baxter technical support assisted the customer in checking their abacus software warning limit settings and discovered that the customer had not created a limit setting for pediatric patients >/= 40kg.Tech support instructed the customer in how to set the warning limits needed.We are submitting this mdr because the baxter (b)(4) manager of medical affairs stated that, if the patient were to receive a hyperosmolar solution, phlebitis can occur.If the phlebitis progresses to a thrombophlebitis, though improbable, this could lead to an adverse patient event including potential patient death.

Manufacturer Narrative

Investigation notes: baxter technical support personnel assisted the customer in how to check their warning limit settings in abacus and discovered that the customer had not created a limit setting for pediatric patients >/= 40kg.Tech support helped the customer set-up the needed osmolarity limit for pediatric patients >/= 40kg.Tech support performed system testing in order to verify that the warning limits flagged appropriately.Method: computer software performance tests conducted.Results: computer/human interface problem.Conclusion: user interface contributed to event.

• Brand Name: ABACUS SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• 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: 4398692
• MDR Text Key: 5302314
• Report Number: 1419106-2015-00001
• 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: 01/05/2015

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: 8300-0046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 53