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

Model Number	3500
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned for repair with report that that syringe rod gasket missing or off.Review of service history found no repair records within 12 months.Review of event history found pump motor drive off post.Functional and visual tests were performed.Complaint confirmed by checking the syringe rod.Found that the gasket was pushed inside the top case.Motor rate error occurred while testing the occlusion test.Device was repaired by installing the new gasket and the left, right clutch, the clutch spring, the worm coupling, and gear.The main cause of customer¿s complaint was the missing the gasket and the motor rate error issue.After replacing the parts, the pump passed all the testing and is fully operational.
Event or Problem Description
It was reported that the syringe arm gasket is off or missing.There was no physical damaged and device was not dropped.The event occurred during preventive maintenance process.There was no delay of therapy.There was no patient involvement.

• Brand Name: MEDFUSION 3500 PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20918636
• Report Number: 3012307300-2024-14843
• Device Sequence Number: 5043375
• Product Code: FRN
• UDI-Device Identifier: 10610586032318
• UDI-Public: (01)10610586032318(11)151221
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2015
• 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