MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP ABACUS SOFTWARE

Model Number 8300-0169

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Overdose (1988)

Event Date 05/16/2015

Event Type  malfunction  

Event Description

The customer reported that an incorrect amount of zinc was pumped for a pt bag prepared using abacus software.After baxter technical support trouble shooting, it was found there were no warning limits set and the customer entered the order incorrectly, entering the type as "electrolyte" instead of "other" which caused the compounder to pump zinc in incorrect values.Per the customer, one pharmacist checked the values of the zinc and noticed that the pumped volume was higher than the ordered volume.The customer ordered 250mcg/kilo for 1100mcg/day.However, the order that was pumped was for 2.45mg (2450mcg) of zinc.Per the customer no adverse events occurred and the pt is fine from this issue.No additional info is available.

Manufacturer Narrative

No product was returned for eval, however the customer provided the physician order form and label, which provided details about the order and what was compounded.Based on the customer report and the orders, this event was determined to have been caused by user error.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.Additionally, the abacus user guide directs the user that errors and inappropriate dosing are possible if appropriate warning limits have not been developed and assigned.Do not use the abacus software without appropriate warning limit sets in place.(b)(4).

• Brand Name: ABACUS SOFTWARE
• Type of Device: ABACUS SOFTWARE
• Manufacturer (Section D): BAXTER HEALTHCARE CORP; 14445 grasslands dr.; englewood CO 80112
• Manufacturer (Section G): BAXTER HEALTHCARE CORP; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: tracey hughes ; 9540 maroon cir; ste 400; englewood, CO 80112 ; 3033909898
• MDR Report Key: 4843882
• MDR Text Key: 5940779
• Report Number: 1419106-2015-00086
• 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: 06/09/2015

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: Other
• Device Model Number: 8300-0169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 06/12/2015
• 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
• Treatment: TPN
• Patient Age: 3 MO
• Patient Weight: 4