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

Model Number 8300-0047

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 12/22/2014

Event Type  malfunction  

Event Description

It was reported that prior to the compounded product leaving the clean room, it was noticed that the contents of the bag did not match the prescription associated with the patient name on the label.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.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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 has been opened to address the reported issue.Should additional, relevant information become available, a supplemental report will be submitted.

• Brand Name: ABACUS
• Type of Device: ABACUS TPN CALCULATION 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: eric cops ; 9540 s. maroon circle, ste 400; englewood, CO 80112 ; 3033909774
• MDR Report Key: 4642784
• MDR Text Key: 20152267
• Report Number: 1419106-2015-00054
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2014

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?: Yes
• Device Operator: Pharmacist
• Device Model Number: 8300-0047
• Device Catalogue Number: 8300-0047
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2014
• Initial Date FDA Received: 03/30/2015
• 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