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

Model Number	4000
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the infant patient received infusion in approximately 20 minutes, and the medication should have been administered over 1 hour.Per reporter, the nurse appropriately programmed the pump, which was confirmed in the pump¿s diagnostics.In less than 20 minutes, the pump started alarming that the syringe infusing the medication was near empty, and within about 5 minutes the syringe was completely empty.According to the pump, 05405 ml was delivered, and there was no remaining volume in the reservoir.The programmed volume to be infused was 1.7250 ml, and the programmed rate was 1.73 ml per hr.No symptoms were reported.
Additional Manufacturer Narrative
A4: 0.56 lbs h3: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
H3 and h6.Codes: updated.Device evaluation: the suspected device was returned for evaluation.The customer reported issue of ¿the pump did not deliver the complete volume and the medication infused faster than it was programmed to¿ was confirmed due to user error as the wrong syringe size was selected.The intended infusion information provided by the customer, the appropriate syringe selection would have been a 3ml syringe, however the infusion history shows the 1ml syringe option was selected instead of 3ml when setting up the infusion.This was further confirmed by checking the sensor diagnostics when 1ml and 3ml syringes are in place.The syringe diameter 0.432 in shown in the infusion history is consistent with a 3ml syringe as a 1ml syringe would have shown a diameter around 0.274 in.No issues were found with the functionality of the pump.Probable cause of complaint was incorrect syringe selection by the user when setting up the infusion.The pump passed all functional testing.No issues found.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: MEDFUSION 4000 SYRINGE INFUSION 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: 24650640
• Report Number: 3012307300-2026-02763
• Device Sequence Number: 18644138
• Product Code: FRN
• UDI-Device Identifier: 10610586043567
• UDI-Public: (01)10610586043567(11)160516
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 05/18/2026

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?: Yes
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 21 DA
• Patient Sex: Male
• Patient Race: Black Or African American