MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS®; ABACUS® TPN CALCULATION SOFTWARE

Model Number 8300-0046

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 04/29/2014

Event Type  No Answer Provided  

Event Description

This report is being filed as the result of a retrospective review of complaints.On (b)(6) 2014, baxter (b)(4) became aware of an incident occurring at (b)(6), where a patient received a tpn therapy bag, which allegedly contained 12% more sodium than was intended.Tpn was discontinued when discovered.The tpn in question was compounded through the use of the abacus® software.Abacus® is a windows®- based order entry software for comprehensive tpn calculations and label printing.During the initial risk assessment of this event, in (b)(6) of 2014, it was incorrectly determined that an over delivery of sodium, in the amount stated in the case, would be unlikely to contribute to an adverse patient occurrence.After additional review, it has been concluded that, although no patient harm was reported, the potential for harm exists; therefore, an mdr report should have been submitted.The newly conducted medical assessment, performed on (b)(6) 2014, states that, although improbable, a 12 percent increase of sodium administered to a critical patient could lead to a significant adverse patient event.

Manufacturer Narrative

((b)(4) society of enteral and parenteral nutrition) and aspen (american society of parenteral and enteral nutrition) recommend sodium dosing at 2 - 5meq/kg/day.Based on the physician order and label information provided by the customer, the prescribed amount of sodium ordered by the facility was a total of 8 meq/kg/day.Based on the 0.8 kg patient weight, the total amount of sodium in the parenteral nutrition bag equals 6.4meq.Given the stated patient weight of 0.8 kg, the expected sodium required in this patient population is 4meq/day based on (b)(4) and aspen recommendations stated above.(b)(4) guidelines for sodium in neonates are based on expert opinion and observational clinical studies.From a clinical perspective, the stated percent increase of sodium of 12% would not be expected to have a noticeable clinical effect.Though improbable, a 12 percent increase of sodium administered to a critical patient could lead to a significant adverse patient event.The exactamix compounder blackbox files were received from the customer and reviewed.The review determined the compounder functioned as expected, and no pumping errors were found.The amount of sodium pumped from the source container into the tpn admixture, as programmed into the compounder by the pharmacist, was correct.

• Brand Name: ABACUS®
• Type of Device: ABACUS® TPN CALCULATION SOFTWARE
• 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: eric cops ; 9540 s. maroon circle, ste 400; englewood, CO 80112 ; 3033909774
• MDR Report Key: 4348355
• MDR Text Key: 5177988
• Report Number: 1419106-2014-00018
• Device Sequence Number: 1
• Product Code: JQP
• 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: Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/19/2014

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?: 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: 04/29/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 DA
• Patient Weight: 1