MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD EM 2400, DISPLAY MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 2400D

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a set up issue during use of an automated compounding device (acd).The reporter stated that a non-vented inlet had been used to compound a sodium chloride vial, rather than a vented inlet.The compounded bags were within the acceptable weight range and were delivered to the patient.The customer later tested a bag from the compounding batch, and reported that the bag had been compounded with ¿almost 0¿ sodium chloride due to the issue.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM 2400, DISPLAY MODULE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE - ENGLEWOOD; englewood CO
• Manufacturer (Section G): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6133460
• MDR Text Key: 61085104
• Report Number: 1416980-2016-17743
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2400D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2017
• 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: Reuse
• Patient Sequence Number: 1