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 halves being worn out from normal use.The clutch half's were replaced clearing up the problem.The damage to the case was also 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: 6906961
• Report Number: 3012307300-2017-02142
• Device Sequence Number: 505702
• 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): 01/05/2018

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: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1