MAUDE Adverse Event Report: BAXTER HEALTHCARE EM2400 REPLACEMENT DISPLAY (2400-DYR)

Model Number 2400DY

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: the event reported to have been occurring over a span of time.The device was not returned for an evaluation.However, baxter personnel have contacted the customer to provide additional user training.Based on the customer report, there was no indication the compounder contributed to this event and the cause of this event was determined to be user error.The exactamix operator manual instructs the user to scan only the bar codes attached to the inlet and the corresponding source container.If an incorrect barcode scan was scanned, the compounder beeps and instructs the user to scan again.For the bar code verification to be effective, it is critical the configuration be set up properly.This event is logged under complaint file number-(b)(4).

Event Description

The facility pharmacy it reported the pharmacy staff had bypassed the product barcode verification for several ingredients during the daily setup process on the exactamix compounder.During daily setup, or when a source container must be replaced, the software guides the user through a process of bar code verification.The user would scan a bar code label on each inlet and each source container to verify that the inlet is attached to the correct container.The pharmacy staff were routinely scanning a set of disjunct barcode labels at this step in order to proceed through the setup wizard, etc.Baxter personnel had emphasized to the customer that this is an improper and unsafe practice and the pharmacy staff are operating the compounder outside of baxter's recommendations.It was strongly advised baxter technical support be called at any time to assist in adding products to the exactamix formulary.There was no report of patient injury, adverse event or medical intervention needed.No additional information is available at this time.

• Brand Name: EM2400 REPLACEMENT DISPLAY (2400-DYR)
• Type of Device: EM2400 REPLACEMENT DISPLAY (2400-DYR)
• 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: 5274543
• MDR Text Key: 32938101
• Report Number: 1419106-2015-00325
• Device Sequence Number: 1
• Product Code: NEP
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2015

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: 2400DY
• Device Catalogue Number: 2400DY
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/08/2015
• 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: N
• Patient Sequence Number: 1