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

Model Number 2400DY

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

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 showed the bags were within range and the final ingredients in this event were within acceptable limit.There was no indication the compounder contributed to this event.This event is logged under complaint file number (b)(4).

Event Description

The customer had called to report bags produced on a exactamix compounder completed delivery before the scheduled completion during patient infusion.The reporter was unsure of the cause of the event since the bags passed inspection prior to release and the facility adds overfill to the bags in order to compensate for priming.There was no reported patient injury or medical intervention.This is report 1 of 3 for this event/patients.No additional information is available.

• 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: 5051098
• MDR Text Key: 24891850
• Report Number: 1419106-2015-00229
• 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: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• 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?: Yes
• Date Manufacturer Received: 08/07/2015
• 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
• Patient Age: 6 YR
• Patient Weight: 17