MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS V3.1 ME

Model Number 8300-0169

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of this event was performed and determined the cause to be use error.The abacus software was found to have performed as intended.By design, it selected the ingredients and calculated volumes appropriately as configured.This event occurred because the user had entered an ingredient into the abacus formulary with an ndc number that corresponded with a different ingredient; a unique ndc should have been used.Additionally, as this ingredient was for testing purposes only, it should have been made unavailable after testing.Furthermore, this testing should have been performed in a testing environment instead of the production environment.The abacus user guide warns: patient injury, including death, can occur as a result of mismatches between test configurations and production configurations.Contact technical support for assistance in the creation of a test environment.Always verify that test configurations cannot be used in the production environment.Finally, pharmacy personnel did not identify the discrepancy between the diluted magnesium sulfate ingredient ordered and the regular magnesium sulfate ingredient used by the pharmacy for tpn production.The abacus user guide warns: serious harm or death may occur if an adequate review isn't completed.The abacus software changes an order to complete only after an authorized user completely finishes and approves an order.A thorough review of all data on each tab in the order entry process will minimize the risk of medication error.If any relevant additional information becomes available, a supplemental report will be filed.

Event Description

It was reported that a tpn order, created using abacus order entry software, included an entry for magnesium sulfate with a concentration that differed from the magnesium sulfate product actually used for production of the tpn order.This resulted in a tpn order that was compounded with four times the intended amount of magnesium sulfate.The tpn order was released and subsequently infused on a patient.The patient was noted to have elevated magnesium levels but did not experience an adverse event or injury.Additionally, no medical intervention was performed or necessary to preclude an adverse event or injury.Additional follow up with the customer revealed the customer had added a diluted magnesium sulfate ingredient entry into the abacus formulary during a test for potential improvements in compounding efficiency.While adding the diluted magnesium sulfate into the abacus formulary, the customer had entered the same ndc code as their regular magnesium sulfate ingredient.The customer did not make the diluted magnesium sulfate unavailable after testing, thereby enabling this ingredient to be available for tpn orders with an ndc code corresponding to a higher concentration magnesium sulfate product.

Manufacturer Narrative

This follow-up complaint is logged under complaint file number (b)(4).Medwatch number mw5063393 was submitted by the customer for this event.The patient received two bags with higher than intended concentration of magnesium bag #1: amount of mag 4 meq/ml ordered (ml): 5.15; amount of mag 4 meq/ml received (ml): 20.62.Bag #2: amount of mag 4 meq/ml ordered (ml): 5.15; amount of mag 4 meq/ml received (ml): 20.62.Baxter technical support reviewed with the customer that if the ingredient was not intended to be used, the administrator should have marked it unavailable following the testing.Additionally, baxter technical support explained that the administrator should have used a test environment and a unique ndc for the different (diluted) product.

• Brand Name: ABACUS V3.1 ME
• Type of Device: ABACUS V3.1 ME
• 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: toni cruz ; 9540 s maroon circle; suite 400; englewood, CO 80112 ; 3033909898
• MDR Report Key: 5823169
• MDR Text Key: 50516799
• Report Number: 1419106-2016-00321
• 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: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

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: Health Professional
• Device Model Number: 8300-0169
• Device Catalogue Number: 8300-0169
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/25/2016
• 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 Weight: 86