MAUDE Adverse Event Report: ST PAUL MEDFUSION; SYRINGE

Model Number 4000

Device Problems Device Alarm System (1012); Failure to Cycle (1142)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Investigation completed on a smiths medical syringe infusion pumps|medfusion 4000 pumps motor rate error was revealed in the event log and during occlusion testing was duplicated using testing at 300ml/hr physical condition of the device revealed visible contamination by the l bracket pole clamp.Action was taken to replace the worm coupling, worm gear and motor bracket.The cause was believe to be greased assembly in the gears by customer.Device has passed all functional testing.

Event Description

Information received a smiths medical syringe infusion pumps|medfusion 4000 pump alarm motor rate error.No patient adverse events reported.

• Brand Name: MEDFUSION
• Type of Device: SYRINGE
• 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; ship to, edina, hennepin, 5; minneapolis, MN 55442
• MDR Report Key: 11352018
• MDR Text Key: 232831405
• Report Number: 3012307300-2021-01392
• Device Sequence Number: 1
• Product Code: MRZ
• UDI-Device Identifier: 10610586043567
• UDI-Public: 10610586043567
• 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: 02/19/2021

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
• Device Operator: No Information
• Device Model Number: 4000
• Device Catalogue Number: 4000-0105-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1