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

Model Number 8300-0169

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Baxter engineering reviewed the abacus database, formula file, event logs, bag label, and mixcheck report, and found that the ingredient premasol 10% was not in the formula file but was part of the order (included on abacus's formula and final container label).It was discovered that the server the formula file was delivered to had insufficient disk capacity for the full formula file and instead created a partial formula file.The formula file was reviewed and the last line that should have listed premasol was not included.During the order creation process, there was a point that the hard drive was almost full and abacus was able to write partial file(s) but after a certain point, files were no longer able to be created.Formula files are small in size (roughly 4kb), which minimizes the probability of occurrence of a partial formula files being created due to insufficient disk capacity.Baxter has not previously received reports of partial file created due to insufficient disk capacity.The reporting facility was made aware of the cause of the reported event and has since allocated more space on the server.Baxter technical services has asked the facility's it to turn on monitoring of the server to ensure it doesn't run out of disk space again.Should additional relevant information become available, a follow-up report will be submitted.

Event Description

It was reported that a tpn order created with abacus was missing an ingredient.The incomplete tpn order, created using abacus v3.1, was compounded and sent out to the patient.The patient experienced a clotted broviac catheter, which was attributed to the incorrect tpn order.There were failed attempts to dissolve the clotted line and the patient may undergo surgery to regain central catheter access.Follow-up with the reporting facility revealed final solution bag was 124 ml in volume instead of the ordered 248 ml and lacked premasol.Towards the end of the tpn solution bag, the catheter line occluded at which point precipitate was noticed.The bag label included all the ordered ingredients, while the mixcheck report (a mixcheck report provides details on orders compounded on the exactamix compounder, such as ingredients, ingredient amounts, overall bag weight, etc.) lacked the ingredient premasol.This mismatch was not detected by the pharmacist and the product was released.The mixcheck report also revealed that a calcium phosphate warning limit alert for possible precipitation was overridden during order creation.A request for additional information was made; however, no additional information has been received at this time.

Manufacturer Narrative

Additional follow-up with the reporting facility revealed the patient did not undergo surgery to regain central catheter access.The patient had been discharged from the hospital and is doing well.Should additional relevant information become available, a follow-up will be submitted.

• 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: 6058040
• MDR Text Key: 58413758
• Report Number: 1419106-2016-00421
• 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: 11/02/2016

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: 09/29/2016
• Initial Date FDA Received: 10/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2016
• 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: N/I
• Patient Outcome(s): Other
• Patient Age: 6 MO