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 Type  malfunction  

Manufacturer Narrative

Weight (b)(6).Date of event: unknown.As the reported event was a software issue and resolved by over the phone by baxter technical services, no product was returned for evaluation.The serial number was not provided; therefore, a manufacturing review could not be performed.Baxter personnel reviewed the information provided and determined the device operated as intended with the issue being caused by use error.The abacus software is intended as a tool which is an adjunct for pharmacy practice.Per the abacus user guide, abacus software does not replace the professional judgment of a pharmacist.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.This complaint is logged as complaint file number-(b)(4).

Event Description

The customer reported a tpn order, created using abacus software had occluded at the patient bedside due to a possible capo4 precipitation in the line.L-cysteine was added to the line and dissolved the precipitate thus restoring treatment.No patient injury or adverse events were reported in relation to this event.During troubleshooting by baxter technical support it was discovered the warning levels for copo4 needed to be reset in abacus.Technical support helped the customer successfullyassign proper warning levels.No additional information available.

• 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: 5463309
• MDR Text Key: 39132468
• Report Number: 1419106-2016-00095
• 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: 02/26/2016

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: Pharmacist
• 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: 02/01/2016
• Initial Date FDA Received: 02/26/2016
• 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 Age: 6 YR