MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD EM2400 DY DISPLAY; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 2400DY

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the display cables of an (b)(4) dy display module had an exposed wire which caused connection issues.It was not specified when in the process this occurred.The customer swapped out the display with their backup, and the device was scheduled to be swapped.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection revealed that the display power cable was damaged/punctured and exposing the inner shield.Functional testing was performed with no issues noted.The reported condition was verified.The cause of the condition was not determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM2400 DY DISPLAY
• 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: 6968732
• MDR Text Key: 90689585
• Report Number: 1416980-2017-08491
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

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: Other
• Device Catalogue Number: 2400DY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/23/2017
• Supplement Dates Manufacturer Received: 12/28/2017
• Supplement Dates FDA Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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