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

Model Number	3500
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: one device was received for evaluation.Service history review indicates that the current complaint is related to reoccurring primary audible alarms for this device.The customer report of both alarms with visual inspection during review of device event log.Previous records show that current complaint is related to previous complaints regarding this device giving the primary audible alarm post error.Probable cause due to electrical component interference.The primary speaker and interconnect board were replaced to resolve the device reoccurring paa error.Functionality was verified by the device completing power-up, plunger travel, occlusion, and flow accuracy testing after all repairs and calibration.
Event or Problem Description
It was reported that during setup that the device asked for the biomed passcode, giving the audible alarm post error, and system failure acu watch dog, has happened twice since they got it back from repair.There were no reported patient involvement and no harm.

• Brand Name: MEDFUSION 3500 SYRINGE INFUSION PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55218
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25034889
• Report Number: 3012307300-2026-04387
• Device Sequence Number: 15713323
• Product Code: FRN
• UDI-Device Identifier: 10610586041242
• UDI-Public: (01)10610586041242(11)200516
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: 04/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown