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

Model Number	4000
Medical Device Problem Codes	Device Sensing Problem (2917); Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was received for investigation.The device was visually inspected and functionally tested.It was found that the pump has battery communication timeout, pump motor drive phase b post, and check syringe plunger sensor errors.The interconnect board was replaced to fix the battery communication timeout issue.The battery was replaced to fix the pump motor drive phase b post error.The plunger tube, left plunger case, and ear clip were replaced to fix the check syringe plunger sensor error.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.The device passed testing following repair.
Event or Problem Description
It was reported that there were multiple failures with the device.There was unknown patient involvement.Evaluation of the returned device found that the pump has battery communication timeout, pump motor drive phase b post, and check syringe plunger sensor errors.
Additional Manufacturer Narrative
B5: additional information was received that there was no patient involvement, and no patient harm recorded.
Event or Problem Description
Additional information was received stating there was no patient involvement, and no patient harm recorded.

• Brand Name: MEDFUSION 4000 SYRINGE INFUSION PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22100031
• Report Number: 3012307300-2025-06308
• Device Sequence Number: 7206864
• Product Code: FRN
• UDI-Device Identifier: 10610586043567
• UDI-Public: (01)10610586043567(11)170106
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: 04/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown