MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS SOFTWARE

Model Number 8300-0168

Device Problem Precipitate in Device or Device Ingredient (1478)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2015

Event Type  malfunction  

Event Description

The customer reported that precipitation was observed in a tpn bag prepared using abacus software.The tpn solution which included zinc and phosphate.No patient injury.In their report, the customer stated they were aware of the potential for precipitation due to the interaction of the zinc and phosphate ingredients.

Manufacturer Narrative

This is report 2 of 2.No product was returned for evaluation and event logs were not provided.However, the customer acknowledged the potential for precipitation when using zinc and phosphate together in solutions and the abacus software user guide warns all users to visually inspect all solutions for precipitation prior to and during administration.This event is logged under complaint file #(b)(4).

• Brand Name: ABACUS SOFTWARE
• Type of Device: ABACUS 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: tracey hughes ; 9540 maroon circle; suite 400; englewood, CO 80112 ; 3033909898
• MDR Report Key: 4826449
• MDR Text Key: 5841767
• Report Number: 1419106-2015-00116
• 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: 06/09/2015

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: Pharmacist
• Device Model Number: 8300-0168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TPN AND UNKNOWN BAG.