MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS SOFTWARE

Model Number 8300-0169

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No product was returned and because a serial number was not provided, a manufacturing review could not be performed.However the customer provided the physician order form and this provided details about the order and what was compounded.Based on the customer report and the review of the physician orders, this event was determined to be related to user error.The abacus user guide directs the user to that the formulary must be correct and up to date so that the abacus software can provide the best information for patient safety.Contact technical support before making changes to the formulary.Do not make changes without working closely with technical support.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 is report 4 of 4.This event is logged under complaint file (b)(4).

Event Description

The customer reported to baxter technical support that the multitrace 4 peds was doubling.Through troubleshooting, it was determined that for the ingredient type, base was selected instead of other for the multitrace 4 peds ingredient.The incorrect ingredient type selection is what caused the doubling of multitrace 4 peds.Baxter technical support instructed the pharmacist to go back into the formulary and select other for the ingredient type.When the formulary type was changed to other, the order was correct and resolved the issue of the multitrace 4 peds ingredient from doubling.When the formulary change was intially done, the customer did not call baxter customer support for assistance.There is no additional information available.No adverse event was reported.The current status of the patient is fine.

• 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: 5094475
• MDR Text Key: 26433207
• Report Number: 1419106-2015-00235
• 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
• Report Date: 09/22/2015

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: Pharmacist
• Device Model Number: 8300-0169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• 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
• Treatment: TPN
• Patient Weight: 7