MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS SOFTWARE

Model Number 8300-0169

Device Problem Use of Device Problem (1670)

Patient Problems Hyperglycemia (1905); Nausea (1970)

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

No product was returned and because a serial number was not provided, a manufacturing review could not be performed.Based on the report, this event was determined to be user error.The abacus user guide directs users to thoroughly review all order data.Serious harm or death may occur if an adequate review isn't completed.The (b)(4) 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 event is logged under (b)(4).

Event Description

The customer reported their tpn order was entered with an incorrect unit dose for dextrose.The prescription ordered was for 15% dextrose but dextrose 15ml/kg was given to the patient via tpn.The patient presented with nausea and high glucose levels.However, the patient recovered from the event and is stable.

• 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: 5246753
• MDR Text Key: 32035261
• Report Number: 1419106-2015-00295
• 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: Physician
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 10/29/2015
• Initial Date FDA Received: 11/24/2015
• 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 Outcome(s): Other
• Patient Age: 16 YR
• Patient Weight: 76