MAUDE Adverse Event Report: BAXTER HEALTHCARE ABACUS SE V3.1 (8300-0168)

Model Number 8300-0168

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

Patient weight: (b)(6).The device was not returned for an evaluation.However, the customer did provide a copy of the label to baxter personnel for review, which provided details about the order.Baxter personnel did provide assistance to the customer with modifying the label and removing the default 8.33 ml/hr rate.Based on the customer report, there was no indication the abacus software contributed to this event and the cause of this event was determined to be user error.The abacus software guide instructs a pharmacist should confirm each template's formula and calculations in order to assure its consistency with the prescription.This event is logged under complaint file number-(b)(4).

Event Description

During a call to technical support for assistance regarding labels and configuration set up, it was reported the physician had ordered 1.9ml/hour, but the nurse had administered a tpn bag, created by using the abacus software, to the patient at the rate of 8.33ml/hour.The patient was infused for 6 hours before the nurse noticed the rate of 8.33ml/hour, instead of the prescribed 1.9ml/hour.There was no report of patient injury, adverse event or medical intervention needed.The customer reported the 8.33 ml/hr rate was the default rate listed on stock bag labels and this rate had not been changed on the 1.9 ml/hr label.No additional information is available at this time.

• Brand Name: ABACUS SE V3.1 (8300-0168)
• Type of Device: ABACUS SE V3.1 (8300-0168)
• Manufacturer (Section D): BAXTER HEALTHCARE; 14445 grasslands drive; englewood CO 80112
• Manufacturer (Section G): BAXTER HEALTHCARE; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: phone vang ; 9540 s maroon circle; # 400; englewood, CO 80112 ; 3037846639
• MDR Report Key: 5295111
• MDR Text Key: 33441556
• Report Number: 1419106-2015-00474
• 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: Health Professional
• Type of Report: Initial
• Report Date: 12/14/2015

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: 8300-0168
• Device Catalogue Number: ABACUS 8300-0168
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/14/2015
• 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 Age: 11 DA