MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM 2400, MAIN MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 2400M

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Visual inspection revealed unknown fluids on the unit and damage to the rotor.Additionally damage to the housing was observed indicating the device may have been dropped or mishandled by the customer.Functional testing was performed which included hi-pot electrical safety test, functional system level system test, and functional system level ctf test with no issues noted.The device passed the functional tests.Device lifestats indicate unit was likely not even used by customer.The device operated as intended.The customer reported issue of lipids leaking was not reproduced or verified, using in house ingredients of 70% dextrose and sterile water.The device met specifications for the reported issue.The reported condition was not verified.A service history review revealed that the device had not been serviced in the last 12 months for the reported issue.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an em 2400, main module automated compounding device (acd) that was used with an em2400 valve set leaked with lipids from port 1.This was found during programming/set up.There was no patient involvement.No additional information is available.

• Brand Name: EM 2400, MAIN MODULE
• 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 ; 2242702068
• MDR Report Key: 14950596
• MDR Text Key: 296056827
• Report Number: 1416980-2022-03520
• 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
• Report Date: 07/07/2022

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: 2400M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 07/07/2022
• 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