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

Model Number 8300-0169

Device Problems Computer Software Problem (1112); Improper or Incorrect Procedure or Method (2017); Programming Issue (3014)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2014

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014, baxter (b)(6) was informed of an incident occurring at (b)(6) healthcare of (b)(6) involving our abacus® software.Abacus® is our windows®-based order entry software used with our 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).While entering a test order the customer used "repeat selected" on the first order after modifying the template.The tpn contained double the requested volumes of multi-trace, m.V.I.And calcium gluconate.The doubling of the ingredients activated multiple oem and institutional warning limits.Baxter technical support instructed the customer on how to correct their set-up in order to eliminate the problem.There was no adverse event involved and no intervention was required; however, we are filing a mdr report because, if repeated, over delivery of an ingredient may require intervention or contribute to a serious patient injury or possible death.

Manufacturer Narrative

Evaluation: method: computer software performance tests conducted.· the software engineering team conducted extensive testing in order to duplicate and correct the problem.Results: software problem.· this issue is being investigated by baxter software engineering through a corrective action preventive action (capa).Conclusions: software / firmware caused event.· this issue is being investigated by baxter software engineering through a corrective action preventive action (capa).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
• MDR Report Key: 4367005
• MDR Text Key: 5290513
• Report Number: 1419106-2014-00017
• 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?: No
• Is this a Product Problem Report?: No
• Device Operator: Pharmacist
• Device Model Number: 8300-0169
• 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?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1