MAUDE Adverse Event Report: ST PAUL MEDFUSION; SYRINGE

Model Number 4000

Device Problem Device Alarm System (1012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Investigation completed on a smiths medical syringe infusion pumps|medfusion 4000 pumps complain of flash memory post error code was revealed in the event hisotry log as well as during testing.This was isolated to the main pc board.The cause was believed to be crc failure found in the program memory during power up self testing.Action was taken to replace the main pcb board.Device then passed all funcitonal testing.

Event Description

Information received a smiths medical syringe infusion pumps|medfusion 4000 pumps had system failure and memory post.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): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11828914
• MDR Text Key: 250798508
• Report Number: 3012307300-2021-04371
• 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,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: 4000-0105-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2016
• 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