MAUDE Adverse Event Report: ST PAUL MEDFUSION 4000 PHARMGUARD TOOL BOX; PUMP, INFUSION

Model Number 4000

Device Problem Application Program Version or Upgrade Problem (2881)

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

Event Type  malfunction  

Event Description

It was reported that during a returned order service test, the green screen failed while performing the update.A hard reset was tried to fix the issue but that didn't work.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

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.No information has been provided to date.

Manufacturer Narrative

Device evaluation: a sample was returned to manufacturing for investigation.Visual inspection and functional testing were performed.Visual inspection of the returned device confirmed that the tamper seals were missing upon receipt, the top and bottom cases were in good condition with no visible contamination.Error code information could not be retrieved from the ehl (event history log) due to no display.The customer reported issue was duplicated during the investigation as the device alarmed constantly with no display upon power up.Root cause of the reported issue is due to customer/user error whereby reprogramming from base unit to the top unit (main board) was incomplete.Uploaded software from the base unit via the interconnect board to the head unit (main board) by performing power point process.Reprogrammed the firmware software to version v1.6.4.The product is beyond a year from the manufacture date and there was no indication of a manufacturing defect during the investigation, so a device history record dhr review was not performed.Service history review identified this device has not been in for service previously.

• Brand Name: MEDFUSION 4000 PHARMGUARD TOOL BOX
• 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; receiving dock; minneapolis, MN 55442
• MDR Report Key: 15711337
• MDR Text Key: 307071702
• Report Number: 3012307300-2022-26595
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4000
• Device Catalogue Number: 4000-0101-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1