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

Model Number	3500-0600-51
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pump failure occurred upon powering on and the case was damaged.No patient injury was reported.
Additional Manufacturer Narrative
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.The device was received a broken/removed tamper seal.Error history log review found force sensor test.The pump was powered on and the force sensor calibration was checked for loose connections.The boards were checked for damage and motor drive and occlusion test were performed.The reported issue was not replicated.The root cause of the reported issue was found to be customer induced; the syringe was loaded during startup.There was also customer induced damage that impacted the device.Actions were taken to mitigate the reported issue: the top case was replaced and preventative maintenance was performed.This mdr was generated under protocol (b)(4).

• Brand Name: MEDFUSION 3500 SYRINGE INFUSION PUMP
• Common Device Name: INFUSION,PUMP
• 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: 15537595
• Report Number: 3012307300-2022-20782
• Device Sequence Number: 12533413
• Product Code: FRN
• UDI-Device Identifier: 10610586043291
• UDI-Public: 10610586043291
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K890120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3500-0600-51
• Device Catalogue Number: 3500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown