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

Model Number 4000-0101-51

Device Problems Display or Visual Feedback Problem (1184); Fracture (1260); Power Problem (3010)

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

Event Type  malfunction  

Event Description

It was reported that the pump would not turn on, nothing on display, and the/top case was damaged.No patient injury or involvement were reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: (b)(4).No causes or potential causes of the customers 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.Visual inspection showed the top case was badly chipped on corners and cracked by tubing guides, the bottom case was cracked by l-bracket, the right plunger case was chipped, outside of pump covered in fluid contamination, and there was some fluid ingression present.A review of the event history log identified no alarms related to the reported problem.During functional testing was unable to duplicate the power up problem but did find fluid ingression on interconnect board and main board.Visual inspection confirmed the top case was physically damaged.The root cause of the issue was customer induced via fluid ingression into the main body of the pump as a result of either the customer's improper cleaning of the pump, or the customer's introduction of excessive fluids to the pumps surface.The root cause of physical damage was due to customer impact.Replaced interconnect board and main board.Replaced top case.Performed power up process, preventative maintenance and all functional tests which passed.

• 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): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16436340
• MDR Text Key: 310162475
• Report Number: 3012307300-2023-01624
• 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
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• 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
• Date Returned to Manufacturer: 02/23/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1