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

Catalog Number 2400B

Device Problems Break (1069); Crack (1135)

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

Event Date 12/13/2021

Event Type  malfunction  

Event Description

It was reported that the foot of the base plate of an exactamix automated compounding device was broken.It was further reported that the foot on baseplate came off and cracked.When moving the compounder, one of the feet broke off.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

H10: the device was received for evaluation.A visual inspection was performed which noted that the base plate is in used condition with chipped paint and scratches to paint finish; fluid stains on unit.The reported condition of foot on base plate came off and cracked was verified.The cause of the reported condition was likely caused by everyday use.There are no functional tests to be performed as this is a non-electro-mechanical item.The components will be replaced to resolve the issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM 2400, BASE PLATE 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: 13206301
• MDR Text Key: 283502567
• Report Number: 1416980-2022-00010
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2400B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2022
• 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: Unknown
• Patient Sequence Number: 1