MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS SOFTWARE

Model Number 8300-0169

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 04/12/2015

Event Type  malfunction  

Event Description

The customer reported they had an over delivery of famotidine.During the initial call with baxter technical support, the customer stated that the order was for 0.5mg/kg and they wanted a total of 1.5mg.Instead, the technician programmed the abacus software for 1.5mg/kg and the patient received 4.5mg of famotidine.No patient injury.Approximately 8 hours into the infusion the error was noticed and the infusion was stopped.No additional information is available.

Manufacturer Narrative

The reported event was an order entry error.The issue was resolved over the phone by baxter technical support and the customer is reducing the programming limit for famotidine, within the abacus software, from 15 mg/day to 1.5 mg/kg/day.No product was returned for evaluation, however the customer provided the physician order form and label that was printed off of abacus.This provided details about the order and what was compounded.Based on the customer report, this event was determined to have been caused by user error.The abacus user guide directs users to thoroughly review all order data because serious harm or death may occur if an adequate review isn't completed.The abacus software changes an order to complete only after an authorized user completely finishes and approves an order.A thorough review of all data on each tab in the order entry process will minimize the risk of medication error.This event is logged under complaint file #(b)(4).

• Brand Name: ABACUS SOFTWARE
• Type of Device: ABACUS SOFTWARE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: tracey hughes ; 9540 maroon circle; suite 400; englewood, CO 80112 ; 3033909898
• MDR Report Key: 4736782
• MDR Text Key: 5772619
• Report Number: 1419106-2015-00099
• 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,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/16/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 8300-0169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PEPCID (FAMOTIDINE)
• Patient Age: 1 MO
• Patient Weight: 3