MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS V3.2 SE

Model Number 8300-0192

Device Problem Use of Device Problem (1670)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

This complaint is logged under (b)(4).Age: unknown but reported as pediatric.Based on the customer report and troubleshooting by baxter technical support (bts), it was determined this event was caused by use error.The abacus user manual warns, changing values can have an impact on the patient's therapy.When this setting is changed, other programmatic settings can adversely affect the amount of ingredients being compounded.Users should not change this value without clearly understanding the impact on the patient's therapy.Errors and inappropriate dosing are possible if appropriate warning limits have not been developed and assigned.Do not use abacus without appropriate warning limit sets in place.Contact baxa technical support for assistance with warning limit sets.The abacus user manual also warns of serious harm or death may occur if an adequate review isn't completed.Abacus 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.

Event Description

It was reported that an abacus user incorrectly entered in a value for the dextrose 70% ingredient resulting in an over delivery of dextrose into a tpn bag.The tpn bag was administered to a pediatric patient; the patient was intended to receive 142 mls of dextrose but received 971 mls.The patient was reported to have experienced hyperglycemia.Normal saline and insulin were administered to resolve this event.The patient is reported to be in stable condition.During troubleshooting by baxter technical support (bts), it was discovered that a user changed the units of measurement from the way the template was originally setup.The user was supposed to enter a value based on percentage of a liter bag but instead they changed the units to milliliters.Baxter technical support (bts) is resolving the issue by working with the facility to set up dextrose warning limits.

• Brand Name: ABACUS V3.2 SE
• Type of Device: ABACUS V3.2 SE
• 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: toni cruz ; 9540 s maroon circle; suite 400; englewood, CO 80112 ; 3033909898
• MDR Report Key: 5884133
• MDR Text Key: 52380929
• Report Number: 1419106-2016-00351
• 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: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/17/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 8300-0192
• Device Catalogue Number: 8300-0192
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/17/2016
• 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
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention