MAUDE Adverse Event Report: ST PAUL MEDFUSION; SYRINGE PUMP

Model Number 3500-0600-01

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Investigation completed on a smiths medical syringe infusion pumps|medfusion 3500 pump.The complaint of syringe plunger arm is missing and gasket binds up was revealed by physically visually inspecting device.The cause was there was not any grease on the plunger tube and the case gasket came loose and was inside the pump.This is believed to be customer induced.Action was taken to replace the gasket and applied a light coat of grease on the plunger tube.

Event Description

Information received a smiths medical syringe infusion pumps|medfusion 3500 pumps malfunctioned.Syringe plunger arm is missing a gasket and binds up.No patient adverse events reported.

• Brand Name: MEDFUSION
• Type of Device: SYRINGE PUMP
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11625060
• MDR Text Key: 244151030
• Report Number: 3012307300-2021-02886
• Device Sequence Number: 1
• Product Code: MRZ
• UDI-Device Identifier: 10610586041242
• UDI-Public: 10610586041242
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3500-0600-01
• Device Catalogue Number: 3500-0600-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1