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

Model Number 2400-DY

Device Problem Inaccurate Delivery (2339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2015

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for an evaluation.However, the customer was able to provide copies of the mixcheck report, which provided details about the compounding process for the orders.The mixcheck report provided by the customer showed the compounder operated as designed and messaged the user that the ingredient was possibly underweight and the overall final bag weight was outside of the recommended +/-3%.Additionally, a manufacturing review was performed and found no nonconformances in relation to the manufacturing of this device.Based on the evaluation of the mixcheck report and the customer's report, the cause of this event has been determined to be user error.The exactamix operator manual warns: it is important to print a mixcheck report for every order, then have a pharmacist review and approve the entire report.The compounder software is not intended to replace the professional judgment or knowledge of a pharmacist or pharmacy technician.This event is logged under complaint file number-(b)(4).

Event Description

The customer contacted baxter technical services to report they had 1 bag, created on an exactamix compounder, which completed delivery 45 minutes earlier than expected during patient infusion.The customer stated the mix-check report for this patient indicated the bag was underweight and outside the acceptable range.This was missed by the staff and the bag was released from the pharmacy.No report of patient injury or adverse events.No additional information is available at this time.

• Brand Name: EM2400 DY DISPLAY (2400-DY)
• Type of Device: EM2400 DY DISPLAY (2400-DY)
• 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: 4947666
• MDR Text Key: 23094301
• Report Number: 1419106-2015-00157
• 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,health
• Reporter Occupation: Pharmacist
• Report Date: 07/28/2015

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: 2400-DY
• Device Catalogue Number: 2400DY
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2013
• 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: 3 YR
• Patient Weight: 15