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

Model Number 2400-DY

Device Problem Delivery System Failure (2905)

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

Event Date 05/14/2015

Event Type  malfunction  

Event Description

The customer initially reported the ingredient na acetate prematurely completed delivery before the scheduled delivery time during compounding.During trouble shooting with baxter technical support, it was determined the flow factor for sodium acetate was set up in the configuration incorrectly, resulting in an over delivery of the sodium acetate ingredient.The flow factor accounts for the ingredient's viscosity, the size and type of its source container, its inlet, its venting and other factors that affect its delivery.The pharmacy manager does not recall that any bags were stopped during compounding and bags with potentially over delivered ingredients were released for patient use.However, no patient injury or adverse events were reported in relation to this event.

Manufacturer Narrative

The device was not returned for an evaluation.However, the flow factors and formulary reports were provided and reviewed; baxter personnel determined the device operated as intended with the issue being caused by incorrectly programmed flow factors.The em2400 operator manual instructs the user to not make any changes to the flow factors unless directed by baxter technical support.Baxter has determined the flow factors for all of the ingredients commonly in tpn.Flow factors affect the delivery volume, so they must be accurate.Additionally, the em2400 operator manual states if flow factors needs to be changed, or a flow factor for a new ingredient needs to be added, contact baxter technical support.(b)(4).

• 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: 4818533
• MDR Text Key: 19314125
• Report Number: 1419106-2015-00088
• 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: 05/14/2015

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: 2400-DY
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2015
• Initial Date FDA Received: 06/04/2015
• 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
• Patient Sequence Number: 1
• Treatment: SODIUM ACETATE