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

Catalog Number 2400DY

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.During visual examination, the display cable was observed to have exposed cables.The reported condition was verified.Due to the nature of the sample, no further testing could be performed.The device did not meet specifications for the reported problem; therefore, the problem was confirmed for nonconforming product.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported there was damage to the exactamix em2400 display module cable at the connection to the display.Upon sample return, the cable was observed to have exposed wires.There was no patient involvement.No additional information is available.

• Brand Name: EM2400 DY DISPLAY
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ECM - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9315092
• MDR Text Key: 166866988
• Report Number: 1416980-2019-06303
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 05413765477584
• UDI-Public: (01)05413765477584
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2400DY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2019
• 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: N
• Patient Sequence Number: 1