MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM1200 DY DISPLAY (1200-DY)

Model Number 1200-DY

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event since (b)(6) 2015.As the reported event was a configuration issue and resolved by over the phone by baxter technical services, no product was returned for evaluation.The serial number was not provided; therefore, a manufacturing review could not be performed.A review of the mix check report indicated that the bags were within range after the configuration changes.Should additional relevant information become available, a follow-up report will be submitted.

Event Description

It was reported that an over-delivery of dextrose was observed during compounding.Customer discarded the bags that were out of range.During troubleshooting, baxter technical support determined that the customer had been using the incorrect inlet and flow factor configuration for dextrose 70%.This issue was resolved by baxter technical support by having the customer update their formulary to correct the inlets and the associated flow factors.There was no patient injury or adverse events reported.No additional information was provided.

• Brand Name: EM1200 DY DISPLAY (1200-DY)
• Type of Device: EM1200 DY DISPLAY (1200-DY)
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: thuy nguyen ; 9540 s maroon circle; suite 400; englewood, CO 80112
• MDR Report Key: 5481905
• MDR Text Key: 39749879
• Report Number: 1419106-2016-00130
• 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
• Type of Report: Initial
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Pharmacist
• Device Model Number: 1200-DY
• Device Catalogue Number: 1200- DY
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2016
• 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