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

Model Number 4000-0105-51

Device Problem Device Sensing Problem (2917)

Patient Problem Balance Problems (4401)

Event Type  malfunction  

Event Description

It was reported that the left syringe plunger was not moving.No patient injury was reported.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Plunger assembly seal was removed/broke.Physical damaged (dent) on lower left front.No error which related to customer reported problem was found in event history log.Flippers were found badly misaligned and were not moving when plunger lever was pressed.The root cause of the reported issue was found to be incorrect assembly in the plunger head by customer.Reassembled the whole plunger assembly.Performed power up process and all functional testing which passed.

• 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): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15603088
• MDR Text Key: 306804729
• Report Number: 3012307300-2022-23995
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586043567
• UDI-Public: 10610586043567
• 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
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4000-0105-51
• Device Catalogue Number: 4000-0105-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1