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

Catalog Number 3500

Device Problem Failure of Device to Self-Test (2937)

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, the top case was broken at lower left edge and left and right cases cracked.A review of the event history log identified occlusion check infusion line.Techs performed occlusion test and check the reading of the force sensor.Testing was unable to duplicate the problem, pump was occluded when pressure build up as it was intended, all the reading of force sensor are within the required specs.No problem was found, pump operated as intended, therefore no root cause could be determined.Performed pm maintenance and all functional tests.Repair was not needed for customer reported problem due to no problem was found.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Udi, report source, and 510k are unknown.No product information has been provided to date.

Event Description

It was reported the device had an occlusion 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; attn: receiving dock; minneapolis, MN 55442
• MDR Report Key: 15550353
• MDR Text Key: 306509300
• Report Number: 3012307300-2022-21742
• 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
• 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: 05/23/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1