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

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 medfusion pump 4000 to prepare a fentanyl drip infusion.The medfusion pump screen stated the following: "confirm system update." the operator could not preform the updat as they were no longer within wifi proximity of the hospital.There was no option to bypass from the screen that was displayed.The operator turned off the pump and then restarted it to only have the medfusion pump display the same "confirm system update" message.This time the operator tried to do the update, but the screen continued to state, "updating system".From the "update system" screen the operator only had the following options: (1) update or (2) biomed.As the operator was still in flight to the referring facility, they could not reach the other medfusion pump 4000, so they decide to use the medfusion pump 3500 that was only reserved for epi infusions.When the operator later reached the facility, they were able to reach the secondary medfusion pump 4000, but it too required an update.Additional information was requested but has not yet been received.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.Device evaluation this report addresses the event that the pump library update was delayed almost 48 hours.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.Additional information h6., corrected data: corrections d1, d2, and g5.

• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12078707
• MDR Text Key: 261505067
• Report Number: 3012307300-2021-06596
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2023
• 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