MAUDE Adverse Event Report: ST PAUL MEDFUSION 3500 SYRINGE INFUSION PUMP; PUMP, INFUSION

Model Number 3500-500

Device Problems Device Alarm System (1012); 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 pump motor not running/ clutch error.No patient injury reported.

Manufacturer Narrative

Other text: b3.Date of event is unknown.H3.Device evaluated by manufacturer and h6.Health effect, evaluation codes: updated.Device evaluation: one device was returned.A visual inspection found both tamper seals broken, a cracked right plunger case and battery door and a missing timing plate spring.A review of the event history log found a motor not running error and a check clutch plunger lever error.During the functional testing, the motor not running error was found during the occlusion test.The check clutch error was unable to be duplicated but there were signs of normal wear and black teflon debris on the clutch halves.The cause of the issues was found to be that the stepper motor no longer operates properly due to normal wear, the motor pin and worm coupling were stuck and would not turn, and there was normal wear of the lead screw, clutch spring and clutch halves.The stepper motor, worm gear, worm coupling, lead screw, clutch spring and both clutch halves were replaced.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.

• Brand Name: MEDFUSION 3500 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16843475
• MDR Text Key: 314276347
• Report Number: 3012307300-2023-04792
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586032318
• UDI-Public: 10610586032318
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040899
• 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: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3500-500
• Device Catalogue Number: 3500-500
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1