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

Model Number	4000
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump had flash memory error, there was no patient involvement and no patient harm.Investigation findings included a travel reverse error, which is a reportable malfunction that could result in interruption of therapy if recurring during device use.
Additional Manufacturer Narrative
One device was returned for analysis of complaint of flash memory error.Investigation found travel reverse error, which is a reportable malfunction that could result in serious adverse event if it occurred during patient use.No service records found from previous 12 months.Review of event log found travel reverse error - check clutch/plunger lever.Visual and functional testing was performed.Confirmed flash memory error during power-up test.Probable cause due to a failure with flash memory of the main printed circuit board (pcb).Device was repaired by replacing the main pcb.Additional findings included a ¿travel reverse error¿.Probable cause due to device aging, normal material characteristics, and normal wear.Device will be repaired by replacing the top case, plunger left case, plunger right case, leadscrew, coupler, worm gear, and clutches.

• Brand Name: MEDFUSION 4000 SYRINGE INFUSION PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24734561
• Report Number: 3012307300-2026-03056
• Device Sequence Number: 10421363
• Product Code: FRN
• UDI-Device Identifier: 15019517070750
• UDI-Public: (01)15019517070750(11)190225
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/30/2026

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: 4000-0106-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown