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

Model Number 8300-0169

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient weight is (b)(6).Device not returned to manufacturer.A review of the abacus and compounder database and event logs, in addition to a review of the bag label, physician's order, and the mixcheck report, found: the formulary and templates were configured correctly and abacus functioned as designed.During order entry, the pharmacist who entered the order into abacus selected the order template from the list of applicable templates.However, the template chosen was unintended for this patient at this time.The template chosen was created previously for use during a time when there was a shortage of potassium phosphate and included a less-concentrated form (0.01429 mmol/ml) no longer in use at the facility.Neither the template nor the ingredient was marked unavailable in abacus after the shortage was resolved.Additionally, the following was found: abacus order comparison feature displayed an indication that the template was different than the one used the day before.Abacus calculated the correct volume of potassium phosphate based on the order form and the ingredient concentration defined.A second pharmacist approved the order within abacus (with the different template and less-concentrated potassium phosphate).Upon order approval, abacus produced a file and printed a formula label that clearly lists the potassium phosphate ingredient and its 0.01429 mmol/ml concentration.Both pharmacists initialed the formula label to indicate review and approval.The order was compounded using an exactamix compounder.Because the less-concentrated form of potassium phosphate was not attached to the compounder, the exactamix mixcheck report listed it to be manually added.The mixcheck report clearly lists the potassium phosphate ingredient and its concentration of 0.01429 mmol/ml.The pharmacist manually injected a higher concentrated potassium phosphate (3 mmol/ml) into the bag.Both pharmacists initialed the mixcheck report to indicate review and approval of the completed solution.Based on this investigation, the cause was determined to be use error.The abacus v3.1 user guide states: 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.While the exactamix 2400 operator manual states: it is important to print a mixcheck report for every order, then have a cosigner (pharmacist) view and approve the entire report, especially the formula name; expected weight, measured weight and difference; manual additions; and details.Should additional relevant information become available, a follow-up repot will be submitted.

Event Description

It was reported that a tpn order, created using abacus v3.1 order entry software, included a higher than intended dose of potassium phosphate.This tpn order was compounded, released, and infused on a patient, who experienced "ventricular instability" and "coded four times" before being resuscitated and airlifted to another hospital for care.The patient is reported to be in stable condition.Follow-up with the reporting facility revealed lab tests confirmed the patient had high potassium levels.Tpn therapy was discontinued, and dextrose and heparin were ordered and administered to stabilize the patient.The facility reviewed the tpn order mixcheck report (a mixcheck report provides details on orders compounded on the exactamix compounder, such as ingredients, ingredient amounts, overall bag weight, etc.) and identified that an incorrect concentration of potassium phosphate was listed on the mixcheck report and that the potassium phosphate was listed as a manual addition to the tpn order.Further investigation by the facility found that an incorrect tpn formula template had been selected and used to create the tpn order in the abacus v3.1 order entry software.The template included a diluted form of potassium phosphate (0.01429mmol/ml) not currently in use by the facility; the facility currently utilizes a higher concentration form of potassium phosphate (3mmol/ml).This wasn't caught by the pharmacists creating or reviewing the tpn order nor was it caught when the potassium phosphate was manually added to the tpn bag.This resulted in the 3mmol/ml concentration of potassium phosphate getting added at the volume intended for the 0.01429mmol/ml concentration.Baxter technical support guided the facility in making the tpn formula template with the 0.01429mmol/ml concentration of potassium phosphate unavailable for use to prevent this issue from occurring in the future.No additional information was provided.

• Brand Name: ABACUS V3.1 ME
• Type of Device: ABACUS TPN 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: heather davis ; 9540 s maroon circle; suite 400; englewood, CO 80112 ; 3033909774
• MDR Report Key: 6017475
• MDR Text Key: 57053533
• Report Number: 1419106-2016-00412
• 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
• Report Date: 10/11/2016

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: Pharmacist
• Device Model Number: 8300-0169
• Device Catalogue Number: N/A
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 10/11/2016
• 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
• Treatment: EXACTAMIX COMPOUNDER
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 6 DA