MAUDE Adverse Event Report: BAXTER HEALTHCARE ABACUS SOFTWARE

Model Number 8300-0169

Device Problems Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339); Application Program Problem: Medication Error (3198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2015

Event Type  Injury  

Event Description

It was reported the pharmacist had approved a tpn order using the "repeat select" function of abacus instead of approving the correct "pending order" and as a result, a previous incorrect order for the patient was completed.This incorrect tpn order was administered to the patient.The facility neonatologist later did review the two orders and found no potential clinical impact to the patient.No report of patient injury or adverse events.No additional information is available at this time.

Manufacturer Narrative

The device was not returned for an evaluation and a serial number was not provided.However, the customer was able to provide screenshots of the erroneous and the intended orders, which verified the differences between the two orders.Based on the customer report, the cause of this event was determined to be user error.The customer facility will provide retraining to their staff.The abacus user guide instructs: label changes must be tested and reviewed by a responsible clinician prior to use.Should additional, relevant information become available, a supplemental report will be submitted.(b)(4).

• Brand Name: ABACUS SOFTWARE
• Type of Device: ABACUS SOFTWARE
• Manufacturer (Section D): BAXTER HEALTHCARE; 14445 grasslands drive; englewood CO 80112
• Manufacturer (Section G): BAXTER HEALTHCARE; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: phone vang ; 9540 s maroon circle; # 400; englewood, CO 80112 ; 3037846639
• MDR Report Key: 4954853
• MDR Text Key: 6190576
• Report Number: 1419106-2015-00155
• 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: 07/30/2015

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 07/30/2015
• 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
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Weight: 1