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

Model Number	3500
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was received for evaluation.The previous service was not related to the current issue.The event history log (ehl) was reviewed.The reported problem was confirmed as inspection of the main printed circuit board (pcb) showed that the super capacitor component had been replaced with a smaller capacitor that doesn¿t have the same specifications as the original.Additional findings included a cracked top casing, cracked plunger casing, and force sensor error.The root cause of the issue was the main board super capacitor error.As a result, the main board, top case, plunger printed circuit board (pcb), plunger case right, plunger case left, and force sensor were replaced.
Event or Problem Description
The customer returned product for super capacitor error; physical inspection found a force sensor error.There was unknown patient involvement.

• Brand Name: MEDFUSION 3500 PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21029370
• Report Number: 3012307300-2024-15557
• Device Sequence Number: 9738960
• Product Code: FRN
• UDI-Device Identifier: 10610586032318
• UDI-Public: (01)10610586032318(11)140114
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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: 11/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2014
• 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