MAUDE Adverse Event Report: ICU MEDICAL, INC. MEDFUSION 3500 SYRINGE INFUSION PUMP; PUMP, INFUSION

Model Number	3500
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the device stating, ¿the device had error message "check syringe plunger sensor" and alarm during power up.¿ during device evaluation the allegation was confirmed due to normal product characteristics of the ear clip causing plunger flipper interference.There was no patient involvement or harm.The unit is being returned for a potential repeat repair; it was recently serviced for a motor rate error.
Additional Manufacturer Narrative
Device evaluation: the suspected device was returned for evaluation.The customer reported issue of "the device had error message "check syringe plunger sensor" and alarm during power up." was confirmed during review of device event log.The error was duplicated during power-up testing when the plunger lever flippers are not positioned fully in the ¿down position¿.Due to the design of the ear clip piece, there can be interference between the ear clip ends and the plunger flippers when the plunger handle is fully closed.Probable cause is due to normal product characteristics of the ear clip causing plunger flipper interference.The interference error is resolved by manually trimming the right face of the ear clip corners flush with the face, removing the interfering material.The error can also be resolved by the user positioning the plunger handle away from the ear clip before powering on the device.The current error is unrelated to the previous repair on 29-jan-2026 of ¿motor rate error¿.

• Brand Name: MEDFUSION 3500 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: 24568556
• Report Number: 3012307300-2026-02271
• Device Sequence Number: 8384593
• Product Code: FRN
• UDI-Device Identifier: 10610586041242
• UDI-Public: (01)10610586041242(11)180522
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 03/11/2026

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: 3500
• Device Catalogue Number: 3500-0600-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown