MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS® SOFTWARE; ABACUS® TPN CALCULATION SOFTWARE

Model Number 8300-0169

Device Problem Application Program Problem: Medication Error (3198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2014

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014 we were informed of an incident involving our abacus® software.Abacus® is our windows®-based order entry software used with our em2400 exactamix compounder.The exactamix compounder is an automated pumping system that compounds multiple sterile ingredients into a finished solution, and is designed for the preparation of total parenteral nutrition (tpn).In this case the customer stated that a patient received a tpn containing two amino acids: travasol (b)(6) 1g/kilo and premasol (b)(6) 1g/kilo.The patient was only supposed to get the travasol.Customer states that a resident pharmacist may have made the change by mistake.There was no adverse event involved and no intervention was required; however, we are filing a mdr report because, if repeated, the event could require intervention or contribute to a serious patient injury or possible death.The event was not caused by a defect or malfunction of the abacus software.If additional information regarding this event becomes available, a follow-up report will be submitted.

Manufacturer Narrative

Evaluation, method: no testing methods performed.There was no alleged defect or malfunction of the baxter device; therefore, there was no need for further device testing.The customer stated that a resident pharmacist may have made the change by mistake.Results: device performed according to specifications.The customer was informed that the ability to make changes to orders can be locked.The customer declined that option as it would require them to call baxter technical support every time they have a shortage and need to make a change.They stated that they will be sure to check their orders more thoroughly.Conclusions: user error caused event.Summary: the investigation found that the cause of the event was due to user error.There was no defect or malfunction of the abacus software.No further action is required at this time.Should additional information regarding this event become available, a follow-up report will be submitted.

• Brand Name: ABACUS® SOFTWARE
• Type of Device: ABACUS® TPN CALCULATION SOFTWARE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 9540 s. maroon circle; englewood CO 80112
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: lou fearing ; 9540 s. maroon circle; englewood, CO 80112 ; 3037846653
• MDR Report Key: 4175084
• MDR Text Key: 15818111
• Report Number: 1419106-2014-00010
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2014

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?: No
• Device Operator: Other
• Device Model Number: 8300-0169
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 10/15/2014
• 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
• Patient Age: 16 MO
• Patient Weight: 10