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

Catalog Number 3500

Device Problem Device Alarm System (1012)

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

Event Type  malfunction  

Event Description

It was reported the primary audible alarm background check.No patient injury reported.

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 was broken and device had a broken top case on left corner.A review of the event history log primary audible alarm background test.An occlusion test was preformed.The tech was unable to duplicate the primary audible alarm background test during occlusion test and was unable to determine the intermittent of the error.The root cause was unable to be determine, interconnect board (high profile c9) and speaker were carefully inspected with no physical or any other damaged was found.The tech replaced interconnect board and speaker for preventive measures.Performed power up process and all functional tests which passed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Udi and pma/510 k are unknown.No product information has been provided to date.

• 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: 15551285
• MDR Text Key: 306657021
• Report Number: 3012307300-2022-21885
• 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: 08/22/2022
• Initial Date FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1