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

Model Number	4000
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3/h6: the suspected device was returned for evaluation.Review of the event history log (ehl) confirmed the reported issue through alarm.The device was visually inspected.A functional test was performed.The plunger pcb had a desoldered transistor.The plunger pcb, force sensor and plunger case were replaced.The service history review had no indication that the complaint was related to a service of the device within the review period.The device passed all functional testing after repair.
Event or Problem Description
It was reported that the pump was not recognizing the syringe size, syringe not in place error.There was no patient involvement.

• 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: 24727401
• Report Number: 3012307300-2026-03014
• Device Sequence Number: 18458979
• Product Code: FRN
• UDI-Device Identifier: 10610586043567
• UDI-Public: (01)10610586043567(11)160303
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: Other
• Device Model Number: 4000
• Device Catalogue Number: 4000-0105-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown