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

Catalog Number	2400M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the green door of a em 2400, main module was damaged.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Correction made to g1: baxter healthcare - englewood 14445 grasslands drenglewood, co.80112 united states (previously submitted as plexus corporation 2500 millbrook drive buffalo grove il.60089 united states).H10: the device was received for evaluation.A visual inspection was performed and found rust spots on the pump door magnets, torn away occlusion detector membrane, top plate paint scratched and chipped, main module cover corroded, damaged rotor assembly keyhole, worn rubber feet and two rubber recessed bumpers.Functional and electrical testing was performed and completed successfully.The reported condition was verified.The small areas of rust and staining did not impact function of the device and is considered cosmetic in nature.The direct cause of the reported issue is end user induced, the unit was not kept clean and dry after ingredient spillage.The pump cover with magnets will all be replaced during the refurbishment process.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM 2400, MAIN MODULE
• Common Device Name: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): PLEXUS CORPORATION; 2500 millbrook drive; buffalo grove IL 60089
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14159935
• Report Number: 1416980-2022-01923
• Device Sequence Number: 2931853
• Product Code: NEP
• UDI-Device Identifier: 00085412482637
• UDI-Public: (01)00085412482637
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

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
• Operator of Device: Other
• Device Catalogue Number: 2400M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown