MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDFUSION 4000 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 received for evaluation.Visual inspection confirmed the reported problem.Additionally, onboard diagnostic tests revealed that the motor and clutch assembly were faulty.The plunger gasket was replaced, and during the diagnostic test, a motor run error was detected.As a result, the motor, clutch, and plunger drive train were replaced.The service history review had no indication that the complaint was related to a service of the device within the review period.
Event or Problem Description
It was reported that the syringe arm gasket is off or missing.The event occurred during preventive maintenance process.There was no patient involvement.Device evaluation produced a motor rate error.

• Brand Name: MEDFUSION 4000 PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20898055
• Report Number: 3012307300-2024-14671
• Device Sequence Number: 14703382
• 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): 12/10/2024

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: 11/13/2024
• Initial Report FDA Received Date: 12/10/2024
• 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