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

Catalog Number	3500
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a motor rate error occurred on a smiths medical medfusion 3500 syringe pump.There were no reported adverse effects.
Additional Manufacturer Narrative
One pump was returned for analysis in poor condition.Visual analysis found the pump was cracked on the right plunger case and battery door.The event history log was unable to be reviewed due to a power up problem and inability to download the history.The field observation could not be duplicated as the pump was inoperable and testing could not be run.It was noted that the whole motor assembly, leadscrew, and clutch halves were badly contaminated causing the motor rate error observed in the field.The pump was repaired and passed functional testing.Based on the evidence, the complaint was confirmed.The root cause was determined to be related to fluid ingression to the plunger head and main body likely due to use of the pump in a manner inconsistent with the instructions for use.This pump is designed to be used in a horizontal position.If the pump is operated in any other position (including vertical), there is an increased potential for fluid leaking into the pump.

• 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: 7086773
• Report Number: 3012307300-2017-02539
• Device Sequence Number: 1079929
• Product Code: FRN
• UDI-Device Identifier: 10610586041259
• UDI-Public: 10610586041259
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/02/2018

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 Catalogue Number: 3500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1