MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS SOFTWARE; ABACUS SOFTWARD

Model Number 8300-0168

Device Problem Programming Issue (3014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2015

Event Type  malfunction  

Event Description

The customer reported when pumping nacl the compounder pumped sodium acetate instead.During the initial call with the customer, baxter technical support performed troubleshooting which included a review of the formulary and it was found the customer had the incorrect ndc code entered in the formulary.The compounded bag was infused to this patient.No patient injury.No medical intervention was needed.This report is in reference to patient 3 of 3.Additional information was requested and is not available.

Manufacturer Narrative

As the reported event was a formulary configuration issue and resolved by over the phone by baxter technical services, no product was returned for evaluation.Should additional, relevant information become available, a supplemental report will be submitted.This event is logged under complaint file #(b)(4).

• Brand Name: ABACUS SOFTWARE
• Type of Device: ABACUS SOFTWARD
• 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: tracey hughes ; 9540 marooon circle; suite 400; englewood, CO 80112 ; 3033909898
• MDR Report Key: 4680236
• MDR Text Key: 19989668
• Report Number: 1419106-2015-00058
• 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: 03/26/2015

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: 8300-0168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 04/10/2015
• 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
• Patient Age: 40 YR
• Patient Weight: 61