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

Model Number 8300-0168

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for an evaluation.However, the set up process was reviewed by the customer and the customer determined that this was a user error.Additionally, baxter personnel also reviewed the information provided and determined the device operated as intended with the issue being caused by incorrect setup.The customer will provide re-training to their operators.The abacus software is intended as a tool which is an adjunct for pharmacy practice.The abacus manual instructs the user to call baxter technical support for any assistance.Abacus software does not replace the professional judgment of a pharmacist.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

Customer called to report the peditrace was ordered incorrectly while using abacus software and the resulting tpn bag was infused to a patient.The facility normally uses peditrace ml/day but it was ordered as ml/kg.The customer reviewed their templates and found they had used an under 12 month old pediatric template for peditrace, instead of the over 12 month old template.However, no patient injury or adverse events were reported in relation to this event.

• Brand Name: ABACUS SE V3.1 (8300-0168)
• Type of Device: ABACUS SE V3.1 (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: 5448960
• MDR Text Key: 38644601
• Report Number: 1419106-2016-00091
• 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: Other
• Type of Report: Initial
• Report Date: 02/19/2016

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?: No
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/19/2016
• 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: 17 MO
• Patient Weight: 10