MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD ABACUS V3.2 SE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 83000192

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/28/2016

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient experienced an unspecified adverse event resulting from an order where dextrose and sterile water for infusion volumes had been switched.The order had been compounded using abacus total parenteral nutrition software.The reporter stated that a warning limit had not been fired during compounding.The order was administered to the patient, resulting in an unspecified adverse event.During troubleshooting, it was found that the warning limit had not been properly set for the order.The technical service representative assisted the customer in properly setting the limit.Treatment and any medical intervention associated with the event were not reported.The patient outcome was not reported.Additional information is not available.

Manufacturer Narrative

Improperly setting the warning limits is a known cause of not receiving a warning limit notification.The labeling provided with this device provides instructions on warning limits and how they can be set up.A review of the label for the product family will be conducted.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ABACUS V3.2 SE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE - ENGLEWOOD; englewood CO
• Manufacturer (Section G): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6270911
• MDR Text Key: 65519834
• Report Number: 1416980-2017-00419
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 83000192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2016
• Initial Date FDA Received: 01/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other