MAUDE Adverse Event Report: ST PAUL MEDFUSION 3500; SYRINGE INFUSION PUMPS

Catalog Number 3500

Device Problem Failure to Sense (1559)

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

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.The tamper seal were removed.Bottom case is not connected to the top case correctly,right plunger case crack,barrel clamp guide is broken also the size pot cable is damage,the main board is contaminated.A review of the event history log identified motor rate error.The techs were unable to perform an occlusion test to verify the motor rate error problem due to broken barrel clamp assembly.The root cause of the motor rate error was attributed to the combination of motor assembly, worm gear, leadscrew and clutch halves were found old, dirty and worn out.The techs replaced motor assembly (stepper motor included), worm gear, leadscrew and clutch halves.Performed occlusion test and all functional tests which passed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product information has been provided to date.

Event Description

It was reported the device had a motor rate error.No patient injury reported.

• Brand Name: MEDFUSION 3500
• Type of Device: SYRINGE INFUSION PUMPS
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15550527
• MDR Text Key: 306899938
• Report Number: 3012307300-2022-21755
• Device Sequence Number: 1
• Product Code: PHO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2022

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: Health Professional
• Device Catalogue Number: 3500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1