MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDFUSION 3500 PUMP; PUMP, INFUSION

Model Number	3500
Medical Device Problem Codes	Failure to Infuse (2340); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump exhibited a check clutch, plunger lever alarm during occlusion test.There was unknown patient involvement, no patient injury was reported.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
H2) device evaluation: d3 - manufacturing plant address, city, and zip code updated.D9 - date returned to manufacturer: 3/20/2025.H3, h6: the device was returned, and the manufacturer representative confirmed the product had reached end of service.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
H2) device evaluation: d9 - date returned to manufacturer: 3/20/2025.H3, h6: the device was returned for root cause analysis and the investigation findings concluded after visual inspection, functional testing, and event history log (ehl) review, the customer problem was duplicated.During motor drive testing the pump displayed a "check clutch" alarm and the ehl showed a motor rate error as well.The cause of the customer reported problem was the clutch was worn out.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.The manufacturer representative confirmed the product had reached end of service.

• Brand Name: MEDFUSION 3500 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: 21026570
• Report Number: 3012307300-2024-15501
• Device Sequence Number: 18397765
• Product Code: FRN
• UDI-Device Identifier: 10610586032318
• UDI-Public: (01)10610586032318(11)140127
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2025

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: 3500
• Device Catalogue Number: 3500-500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 03/20/2025; 04/24/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 04/18/2025; 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2014
• 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