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

Model Number	4000
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3/h6: investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It is stated that the pump is off and triggers alarms spontaneously.It is unable to diagnose.And the screen is blank.There is unknown patient involvement and unknown patient harm.
Additional Manufacturer Narrative
H3, h6, h7 and h9: updated.The suspect pump was returned for evaluation.Visual inspection was performed and was confirmed that there were no anomalies noted related to the complaint.The service history review was performed, and it was confirmed that there was no previous repair noted.The allegation made by the complainant was confirmed.The probable root cause of the event was due to a faulty main printed circuit board (pcb).

• 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: 24951656
• Report Number: 3012307300-2026-04037
• Device Sequence Number: 10093031
• Product Code: FRN
• UDI-Device Identifier: 10610586043567
• UDI-Public: (01)10610586043567(11)141126
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0864-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown