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

Model Number	3500
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a clutch plunger lever issue occurred on a medfusion® 3500 syringe pump.There was no reported patient involvement.
Additional Manufacturer Narrative
One pump was returned for analysis in used condition.Visual inspection showed that the pump was in poor condition; the top case was chipped and cracked and the bottom case was damaged.The pump history log confirmed that there was a check clutch/plunger lever error.It was determined that the check clutch/plunger error was due to the clutch being released during an infusion.Older parts of the clutch were replaced as a preventative measure and the damage to the case was repaired.The pump passed all function and delivery tests following the repair.

• Brand Name: MEDFUSION® 3500 SYRINGE PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6906945
• Report Number: 3012307300-2017-02141
• Device Sequence Number: 13731033
• Product Code: FRN
• UDI-Device Identifier: 10610586041259
• UDI-Public: 10610586041259
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111386
• 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): 01/04/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1