MAUDE Adverse Event Report: ST PAUL MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP; PUMP, INFUSION

Model Number 4000

Device Problem Application Program Version or Upgrade Problem (2881)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that during a transport flight to a referring facility, the healthcare provider turned on the pump to prepare a fentanyl drip infusion outside wifi parameters and it did not work.No patient injury was reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review could not be performed as the serial number was unknown.No root cause could be determined as the complaint could not be confirmed.

• Brand Name: MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP
• Type of Device: PUMP, INFUSION
• 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: 13516954
• MDR Text Key: 285572420
• Report Number: 3012307300-2022-03255
• Device Sequence Number: 1
• Product Code: FRN
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1