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

Model Number	3500-0600-82
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).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.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.Both tamper seals were intact.Right case was found cracked.Auxiliary control unit watchdog failure and primary audible alarm post.Was found in pump event history log.Reported problem was unable to be duplicated during power-up test.The root cause of the reported issue was unable to be determined.Actions were taken to mitigate the reported issue: replaced interconnect board and primary speaker as a preventive measure.
Event or Problem Description
It was reported that the device was presenting with auxiliary control unit watchdog failure and primary audible alarm post.No patient injury was reported.

• Brand Name: MEDFUSION 3500 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: 15612011
• Report Number: 3012307300-2022-24244
• Device Sequence Number: 7374820
• Product Code: FRN
• UDI-Device Identifier: 10610586043017
• UDI-Public: 10610586043017
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 10/14/2022

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: 05/03/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/14/2022
• 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