MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS V3.1 ME; ABACUS TPN SOFTWARE

Model Number 8300-0169

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 07/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As the reported event was a software issue and resolved by over the phone by baxter technical services, no product was returned for evaluation.A capa investigation was performed for this issue and determined the cause to be a software design issue.A safety alert for this issue was sent to abacus customers.This issue was corrected in abacus software version 3.2, which was released in december 2015.Should additional relevant information become available, a follow-up report will be submitted.

Event Description

It was reported that upon scanning a compounding order label created using abacus v3.1, the patient name and order displayed on the compounder did not match the label, indicating a mismatch between the patient name and the order to be compounded.This issue was resolved by baxter technical services by having the customer manually increment the order number beyond the last order saved in the abacus database.No orders with incorrect patient names were compounded.There was no patient involvement.During follow-up with the facility it was discovered a sister facility, who shares the same abacus database, had to restore the database during their upgrade to abacus v3.2.However, the sister facility had failed to notify the reporting facility of the database restore, which caused the scanned order to not match the order label because the reporting facility was not aware they needed to increment their order numbers.No additional information is available.

• Brand Name: ABACUS V3.1 ME
• Type of Device: ABACUS TPN 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: heather davis ; 9540 s maroon circle; suite 400; englewood, CO 80112 ; 3033909774
• MDR Report Key: 5971187
• MDR Text Key: 55427278
• Report Number: 1419106-2016-00396
• 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: Pharmacist
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/22/2016

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
• Device Catalogue Number: N/A
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/22/2016
• 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
• Removal/Correction Number: Z-1628-2015
• Patient Sequence Number: 1