MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS SOFTWARE

Model Number 8300-0169

Device Problems Use of Incorrect Control/Treatment Settings (1126); Programming Issue (3014)

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

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, based on the customer report, this event was determined to be related to user error.The facility will be switching from aminosyn ii 10% to travasol 10% and will set up appropriate curve data for travasol.The abacus user guide directs users to thoroughly review all 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.The abacus user guide also warns that users should keep in mind the potential of precipitate formation during parenteral nutrition admixture, even when using appropriate curve data, and that decisions regarding drug therapy must be based on professional judgment.This event is logged under complaint file (b)(4).

Event Description

The customer reported that when entering orders containing aminosyn ii 10% into abacus, they were using clinamix 10% curve data since they did not have curve data for aminosyn ii 10%.Curve data represents a comparison of a given tpn order to calcium phosphate solubility, as specified by drug/solution templates provided by manufacturers.This data is presented in abacus as a graph showing the likelihood of precipitation formation in the order.In this situation, using inaccurate curve data could result in the formation of precipitate in the compounded product.The compounded product was released for patient use.However, there was no report of patient injury or adverse event in relation to this event.No additional information is available.

• 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: 4954875
• MDR Text Key: 23226434
• Report Number: 1419106-2015-00156
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: BD
• 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: 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: 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: 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
• Patient Sequence Number: 1