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

Catalog Number 2400M

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the green pump door of an exactamix automated compounding device has missing parts.It was further reported the green door had missing screws.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.A visual inspection was performed which noted the device was missing the screws from the green door.Functional and electrical testing was performed with no issues noted.The reported condition was verified.The cause of the missing screws was likely from normal everyday use.To correct the condition, the door and screws will be replaced during refurbishment of main module.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM 2400, MAIN COMPOUNDER MODULE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11089748
• MDR Text Key: 224761657
• Report Number: 1416980-2020-08161
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 00085412482637
• UDI-Public: (01)00085412482637
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

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: 12/18/2020
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.