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

Catalog Number	2400DY
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9315092
• Report Number: 1416980-2019-06303
• Device Sequence Number: 11390427
• Product Code: NEP
• UDI-Device Identifier: 05413765477584
• UDI-Public: (01)05413765477584
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 2400DY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1