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

Model Number	4000
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the pump had error message after force sensor test.There was unknown patient involvement.
Additional Manufacturer Narrative
One device was returned for repair with complaint that the pump had error message after force sensor test.Alarm history reviewed and found no abnormal alarms.Service history review identified the complaint was not related to a previous service of the device within the review period.Complaint was verified when reviewing the alarm history.Visual/functional testing was performed.The cause of the complaint was found to be a force sensor that was out of calibration.The calibration was verified in the diagnostics section of the pump.

• Brand Name: MEDFUSION 4000 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 lane n.; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21394962
• Report Number: 3012307300-2025-01938
• Device Sequence Number: 15602196
• Product Code: FRN
• UDI-Device Identifier: 15019517070996
• UDI-Public: (01)15019517070996(11)231218
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 4000-0106-231
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/13/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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