MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS V3.1 SE (8300-0168)

Model Number 8300-0168

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This issue was resolved through assistance provided by baxter technical support (bts).Based on the customer report and troubleshooting performed by bts, this event was determined to be use error.Per the abacus user guide, 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 complaint is logged as complaint file number (b)(4).

Event Description

It was reported that during tpn order creation using abacus software, the customer had inadvertently ordered dextrose 15% instead of dextrose 10%.This tpn order was produced, released, and infused on a nicu patient.There was no report of patient injury, adverse event, or medical intervention in relation to this event.During troubleshooting by baxter technical support (bts), it was discovered that while using a stock template in abacus for dextrose 10% orders, the user had changed the dextrose concentration to 15% for one order but then failed to change the concentration back to 10% before entering subsequent orders.A pharmacist had reviewed the orders but failed to notice the discrepancy.Bts helped the customer lock the dextrose 10% and 5% templates in order to disable the option to modify the concentration during order entry.The customer was also instructed to contact bts any time a new concentration template needs to be created.No additional information.Report 5 of 11.

• Brand Name: ABACUS V3.1 SE (8300-0168)
• Type of Device: ABACUS V3.1 SE (8300-0168)
• 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: 5508993
• MDR Text Key: 40637681
• Report Number: 1419106-2016-00123
• 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: 03/17/2016

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: 8300-0168
• Device Catalogue Number: 8300-0168
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/17/2016
• 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 Age: 5 DA
• Patient Weight: 3