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

Catalog Number 2400M

Device Problems Break (1069); Corroded (1131)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

It was reported that the main module of an automated compounding device (acd) had corrosion and the rotor door was not securing.This was observed during setup.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The actual device was received for evaluation.Visual inspection was performed and found unit in slightly used condition, main housing has some oxidation on the bottom copper coating, appearing as corrosion, and one pump door cover magnet was found to be reversed, causing the pump door cover to not fit snugly on the top plate.Functional system level testing was also performed, with no issues noted.Although the device passed functional testing, the pump door cover does not meet specifications due to the reversed magnet.The reported condition was verified.The cause of the reported conditions could not be determined.However, the probable cause of the reported issue of corrosion is due to customer spilling ingredients and not cleaning up ingredient spills to keep the housing copper paint surface clean and dry after compounder operation.The probable cause of the door not securing is one of the pump door magnets apparently fell out and customer put it back in, in the wrong polarity, which causes the pump door cover to not fit securely.The main housing will be replaced, and door magnet will be installed and secured properly in the right orientation or polarity during the service refurbishment process to correct the reported issues of with the device.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.

Manufacturer Narrative

The device was received for evaluation.An external visual inspection was performed, and it was noted that the device was in slightly used condition.The main housing had some oxidation on the bottom copper coating, appearing as corrosion, and one pump door cover magnet was found to be reversed, causing the pump door cover to not fit snugly on the top plate.Pre-evaluation testing was performed with passing results with no errors despite the reversed magnet.Functional system level testing was also performed with no issues noted.The reported condition was verified.The cause of the areas of oxidation or corrosion could not be determined; however, a probable cause was due to customer spilling ingredients and not cleaning up ingredient spills to keep the housing copper paint surface clean and dry after compounder operation.The main housing will be replaced, and door magnet will be installed and secured properly in the right orientation or polarity during the service refurbishment process to correct the reported issues of with the device.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.

Manufacturer Narrative

Correction: removal of information in section f related to importer - the follow-up #1 report inadvertently included information in f7: report type and f7: follow - up #.This information is being removed as this mdr is a manufacturer mdr (and not an importer mdr).Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM 2400, MAIN MODULE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15512211
• MDR Text Key: 306165946
• Report Number: 1416980-2022-05196
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2022

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: 09/14/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 09/28/2022; 10/31/2022
• Supplement Dates FDA Received: 10/24/2022; 11/21/2022
• 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: A
• Patient Sequence Number: 1