MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS® SOFTWARE; ABACUS® TPN CALCULATION SOFTWARE, PRODUCT CODE: JQP

Model Number 8300-0046

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2014

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 which is 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 their abacus template had dextrose grams/kg/day and the doctors` order was grams/bag and they would calculate to %/bag and enter that value into abacus.Baxter technical support informed the customer that this conversion was not correct.Technical support, along with the baxter (b)(4) manager of medical affairs provided assistance to correct their abacus template to reflect the denominator and numerator of how the doctor is ordering the dextrose.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.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

Investigation summary: method: software evaluation: · the customer stated that the abacus template had dextrose grams/kg/day and the doctors' order was grams/bag so they would calculate to %/bag and enter that value into abacus, which resulted in the incorrect delivery of dextrose to a patient.· baxter technical support set up a file exchange login so the customer could upload their database and fax the doctors' order and mix check report for review.Results: device performed according to specifications: · during the review of the documents, the baxter manager of medical affairs discovered that the dilutional warning limit was only attached to the adult patient type.· technical support assisted the customer to associate the dilutional warning limit to the neonatal patient type which resolved the issue.Conclusions: device performed according to specifications.User error caused event: · there was no defect or malfunction found with the abacus software.The event was due to a user error.Summary: the investigation found that the dilutional warning limit was only attached to the adult template.Technical support associated the max dilution to the neonatal patient type and verified that the warning limit was flagged properly.No further action is required at this time.If additional information regarding this event becomes available, a follow-up report will be submitted.

• Brand Name: ABACUS® SOFTWARE
• Type of Device: ABACUS® TPN CALCULATION SOFTWARE, PRODUCT CODE: JQP
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 9540 s. maroon circle; englewood; colorado 80112
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: lou fearing ; 9540 maroon circle; englewood, CO 80112 ; 3037846653
• MDR Report Key: 4133150
• MDR Text Key: 4922632
• Report Number: 1419106-2014-00009
• 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: 09/22/2014

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: Pharmacist
• Device Model Number: 8300-0046
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 10/01/2014
• 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