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

Model Number 4000-0101-51

Device Problem Mechanical Problem (1384)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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 the device motor stopped working.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Other text: b3: date of event unknown.One infusion pump was received for evaluation.Visual inspection found both seals broken and 3rd party seals present, cracked right plunger case.Event history log shows "motor not running".At start of occlusion test "motor not running" was found.Checked lead screw nut tightness.The cause of the reported issue was the lead screw nut was tightened too much by either the customer or 3rd party vendor.Adjusted lead screw nut with.002" shim tool.Also replaced lead screw and both clutch halves due to normal wear.Performed power up process, preventive maintenance and all functional tests which passed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint., corrected data: health effects ? clinical signs and symptoms or conditions updated health effects? health impact updated.

• Brand Name: MEDFUSION 4000 PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16899743
• MDR Text Key: 314906286
• Report Number: 3012307300-2023-05441
• 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: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4000-0101-51
• 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: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1