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

Model Number 2400DXR

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 03/09/2015

Event Type  malfunction  

Event Description

The customer had called to report bags that completed delivery before the scheduled completion during infusion.The customer wanted to ensure the compounder was working as intended and requested review of the compounding data.Additional follow-up with the customer revealed that they have the resolved the reported issue on their own and are no longer investigating this event.No report of patient injury.Multiple report: 1 of 2 for this event.No additional information is available at this time.

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.Additionally, no nonconformance was found in relation to the report of this device.(b)(4).

• Brand Name: REPLACEMENT EM2400 NEW DISPLAY (2400-DXR)
• Type of Device: REPLACEMENT EM2400 NEW DISPLAY (2400-DXR)
• 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: 4650151
• MDR Text Key: 17585034
• Report Number: 1419106-2015-00038
• 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: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2400DXR
• Device Catalogue Number: 2400DXR
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRIZM PUMP
• Patient Age: 56 YR
• Patient Weight: 85