MAUDE Adverse Event Report: BAXTER HEALTHCARE ABACUS ME V3.1 (8300-0169)

Model Number 8300-0169

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for an evaluation.Additional followups were attempted by baxter technical support, and the director of pharmacy had refused to provide any additional information as it was an entry error made by their staff.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.(b)(4).

Event Description

The customer reported dextrose was ordered as gms/kilo, instead of gms/100ml on the abacus software.The resulting tpn order was administered to a patient.However, there was no report of patient injury, adverse event or medical intervention needed.No additional information is available at this time.

• Brand Name: ABACUS ME V3.1 (8300-0169)
• Type of Device: ABACUS ME V3.1 (8300-0169)
• 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: 5295498
• MDR Text Key: 33452380
• Report Number: 1419106-2015-00475
• 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: 12/15/2015

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: 8300-0169
• Device Catalogue Number: ABACUS ME V3.1 (8300-0169)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2015
• 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