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

Catalog Number 2400DX

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 06/18/2018

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 module of an exactamix compounder had a frayed cord with exposed wires.It was not specified when in the process this was noted.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection revealed that the power/communication cable insulation was punctured, exposing the ground shielding.The internal wires were not exposed.The reported condition of a frayed cable was verified.The cause of the condition was determined to be that the display cable was not properly routed through the cut-out slot of the main module cover, which led to the tubing being punctured from the weight of the main module sitting on the cable.The display was removed from service.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM2400 NEW 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: 7718990
• MDR Text Key: 115022267
• Report Number: 1416980-2018-04618
• 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,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2400DX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2018
• 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