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

Catalog Number 2400L

Device Problem Microbial Contamination of Device (2303)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a load cell module had microbial growth.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d9, g3, h3, and h6.H10: the device was received for evaluation.A visual inspection was performed and found a scratched\stained bag pan with unknown fluids on the unit.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM 2400, LOAD CELL MODULE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11608400
• MDR Text Key: 243577098
• Report Number: 1416980-2021-01833
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 00085412482613
• UDI-Public: (01)00085412482613
• Combination Product (y/n): Y
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

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: 2400L
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 04/02/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1