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

Model Number 4000

Device Problems Device Alarm System (1012); Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the pump exhibited a blank display and alarming.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

H10: device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.The customer reported problem was not related to any previous repair.The device was received with top case crack/chip by the front right and left bottom corners.No visible signs of contamination.No tamper seal was on the device.No evidence of the issue was found in the event history log due to the issue of constant alarm with no display.The reported complaint was verified.The device powered up with constant alarm and with no display.The reported problem was due to y the expulsor; however, no problem was found for the power issue.The root cause was due to an incomplete software program update.For corrective action software upload from base unit (interconnect board) to head unit (main board) was done by performing power point process.The root cause was traced to user interface.The product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a device history record review was not performed.Service history review identified this device has not been in for service previously.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: MEDFUSION 4000 PUMPS
• 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: 15576543
• MDR Text Key: 307017631
• Report Number: 3012307300-2022-23193
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586040818
• UDI-Public: 10610586040818
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: 4000-0101-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1