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 Hyperglycemia (1905)

Event Date 02/23/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A baxter technical service representative (tsr) received the abacus event logs, compounder database, black box files, mix check reports, label, original label, and pat file folder.The tsr sent the information to support services.A complete review of the information showed that the user manually selected the patient order instead of using the bag label via the scanner.In doing so the user selected the wrong patient order.The compounder black box data was evaluated.Upon evaluation, there is no evidence that the em2400 compounder or the compounder software contributed to the user manually selecting the incorrect patient¿s order and pumping the tpn bags.The data provided shows that the bag produced by this compounder, without any environmental or physical interference, should have been acceptable for clinical use, except for it being for the wrong patient.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an abacus v3.2 se printed a label with correct patient information, however when scanned on the compounder, a different patient formula was populated.The patient experienced hyperglycemia as a result with a blood glucose levels in the upper 500's.The intravenous infusion was stopped and the glucose level were checked frequently until they normalized.The corresponding mix check report also had the incorrect patient information listed.The customer stated that in abacus the order was created and completed and then they changed the patient name and re-printed the label.This event occurred during use of the device.No additional information is available.

• 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: 7367989
• MDR Text Key: 103393417
• Report Number: 1416980-2018-01581
• 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,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/23/2018

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 Catalogue Number: 83000192
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/23/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other