MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS SOFTWARE

Model Number 8300-0169

Device Problem Precipitate in Device or Device Ingredient (1478)

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

Event Date 01/26/2015

Event Type  No Answer Provided  

Event Description

The pharmacists at sunrise hospital and medical center called baxter technical services on (b)(6) 2015 regarding a recent precipitation in a total of 2 bags involving 2 patients.The pharmacists reported these bags were hooked up to the patients at the time of the precipitation.This report is in reference to patient 1 of 2.

Manufacturer Narrative

Method: computer software performance tests conducted.Results: no failure detected.Conclusion: user interface contributed to event.Software data reviewed.

• 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: 4553095
• MDR Text Key: 5457018
• Report Number: 1419106-2015-00014
• 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,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8300-0169
• Device Lot Number: UNKNOWN
• Other Device ID Number: EXPIRATION DATE UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 MO
• Patient Weight: 5