MAUDE Adverse Event Report: ST PAUL MEDFUSION; SYRINGE

Model Number 4000

Device Problem Device Alarm System (1012)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Investigation completed on a smiths medical syringe infusion pumps|medfusion 4000 pumps complaint of motor rate error and plunger rotates was found to be customer induced.The event log revealed motor rate error but not able to be duplicated during testing, however the plunger head would rotate.This was isolated to the screws broken off the plunger tube in the carriage causing the plunger to rotate.Action was taken to replace the plunger tube with carriage.Also replaced was worm coupling and gear as a preventative measure for motor rate error in history.Device passed all functional testing.

Event Description

Information received a smiths medical medfusion syringe pump alarms motor rate error and plunger rotates.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; lana haecherl; minneapolis, MN 55442
• MDR Report Key: 11405475
• MDR Text Key: 234473490
• Report Number: 3012307300-2021-01695
• Device Sequence Number: 1
• Product Code: MRZ
• UDI-Device Identifier: 10610586040818
• UDI-Public: 10610586040818
• 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: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• 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: 4000-0101-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2014
• 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