MAUDE Adverse Event Report: ICU Medical, Inc. Medfusion 4000 Syringe Infusion Pump; Pump, Infusion

Model Number	4000
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during inspection of the returned medfusion 4000 syringe infusion pump, a travel course error was confirmed through review of the alarm history.There was no patient involvement; however, no patient harm or adverse event was reported.
Additional Manufacturer Narrative
B3 ¿ date of event: the exact date of the event is unknown; therefore, the first day based on the icu medical awareness date was entered as the event date.The suspect pump was returned for evaluation.The event history log (ehl) was reviewed and confirmed the reported travel course error.A review of the device service history identified no repairs within the previous 12 months.Visual inspection and functional testing were performed, and the travel course error was verified.Inspection of the clutch and plunger was conducted, and the complaint was confirmed through alarm history review.Corrective actions included replacement of the plunger cable, clutch, lead screw, and motor.Probable cause was travel course error.The device passed all functional testing after repair.

• Brand Name: Medfusion 4000 Syringe Infusion Pump
• Common Device Name: Pump, Infusion
• Manufacturer (Section D): ICU Medical, Inc.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50946144
• Report Number: 3012307300-2026-09053
• Device Sequence Number: 18547782
• Product Code: FRN
• UDI-Device Identifier: 15019517069624
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 4000-0106-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown