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

Model Number	3500
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One medfusion 3500 pump was returned for analysis.Visual inspection performed, and product found with cracked top case corners, right plunger case, bottom case by l-bracket and ac receptacle.Event history log review was performed and found evidence of reported problem.Visual inspection, and occlusion test were performed.The customer reported problem was confirmed.According to the investigation, motor rate error found at occlusion test.The investigation replaced the pump stepper motor, old motor mount, worm gear, worm coupling, lead screw and both clutch halves, installed the delrin washer.Performed occlusion test, pm and all functional testing passed.The problem source of the reported problem is user normal wear (pump is over 16 years old).
Event or Problem Description
Information was received that this smiths medical cadd medfusion 3500 pump exhibited motor not working.No reported adverse effects.
Additional Manufacturer Narrative
Other, other text: a1) new information was received that there was no patient involved in the reported event.

• Brand Name: MEDFUSION 3500 PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10776239
• Report Number: 3012307300-2020-10921
• Device Sequence Number: 16428667
• Product Code: FRN
• UDI-Device Identifier: 10610586041259
• UDI-Public: 10610586041259
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: No Information
• Device Model Number: 3500
• Device Catalogue Number: 3500
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1