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

Model Number	3500-0600-82
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: 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 the top and bottom of the cases are in excellent condition.Cracked right plunger case and no visible contamination.Customer?s reported issue was duplicated.Dowel pin came out of plunger head mount.The root cause of the reported issue was determined.The cause of the issue is known and is design related.Actions taken to mitigate the reported issue: replaced plunger head mount and dowel pin.Performed calibration on the pump and passed all the functional tests.
Event or Problem Description
It was reported that syringe clip is not retracting.No patient injury reported.

• Brand Name: MEDFUSION 3500 WIRELESS SYRINGE INFUSION PUMP
• Common Device Name: 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: 15633761
• Report Number: 3012307300-2022-25129
• Device Sequence Number: 5911664
• Product Code: FRN
• UDI-Device Identifier: 10610586043017
• UDI-Public: 10610586043017
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K111386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2022

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: 3500-0600-82
• Device Catalogue Number: 3500-0600-82
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2014
• 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