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

Catalog Number 3500

Device Problem Patient Device Interaction Problem (4001)

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

Event Type  malfunction  

Event Description

It was reported that no high pressure alarm occurred while running and no therapy was delivered to the patient.No patient injury reported.

Manufacturer Narrative

This mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.Physical condition of the device showed cracked on both plunger case and bottom case, keypad and keypad support lens also were found damaged.Customer?s reported issue was not duplicated and during occlusion test.No problem was found.Pump occluded when pressure was building up also all the force reading were within the required specifications.The root cause of the reported issues was not determined.No problem was found.Pump was operated as intended.Actions taken to mitigate the reported issue: performed preventive maintenance and all functional tests.Repair was not needed per customer reported problem due to no problem was found on pump.D4: udi information is unknown.

• 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): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15658031
• MDR Text Key: 302265628
• Report Number: 3012307300-2022-26046
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890120
• 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: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1