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	04/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Upon investigation of a medfusion 4000 pump 'syringe plunger not in place error' was found in the events log history.This is a high priority alarm which will stop any ongoing infusion which confirms the initially reported event.There was no patient involvement, and no patient harm reported.
Additional Manufacturer Narrative
The suspected product was returned for evaluation.Visual inspection and functional testing was carried out.Upon visual inspection cracked plunger case was noted.Upon functional testing syringe recognition check failed.Event history log was reviewed where syringe plunger not in place was found.The reported event was confirmed.Found missing tamper seals and the rack gear flippers where not aligned/installed properly.Correcting the rack gear flipper installation corrected the problem.Replaced both plunger cases.Recalibrated all sensors, passes all functional testing.

• 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: 25183835
• Report Number: 3012307300-2026-05065
• Device Sequence Number: 10543423
• Product Code: FRN
• UDI-Device Identifier: 10610586043567
• UDI-Public: (01)10610586043567(11)170217
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/15/2026

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: 04/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2017
• 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