MAUDE Adverse Event Report: ICU MEDICAL, INC. MEDFUSION 4000 PUMP; PUMP, INFUSION

Model Number	4000
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the suspected device was returned for evaluation.The customer reported issue of ¿during testing there was a motor issue¿ was verified through visual inspection.Probable cause was tampering to motor assembly.Disassembled and reassembled drive train and motor assembly to resolve the reported issue.The device passed all functional and delivery tests after the repair.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.
Event or Problem Description
The customer returned the device stating, ¿during testing there was a motor issue¿; during device evaluation the complaint was confirmed due to tampering to motor assembly.There was no patient involvement or harm.

• Brand Name: MEDFUSION 4000 PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24885089
• Report Number: 3012307300-2026-03735
• Device Sequence Number: 9851475
• Product Code: FRN
• UDI-Device Identifier: 10610586043567
• UDI-Public: (01)10610586043567(11)160127
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K111386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2026

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: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: 4000-0105-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown