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

Model Number	3500-0600-82
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).A manufacturing device history record review was not performed because the results of the complaint investigation did 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.Visual inspection showed there was not any external damage noted.There was depleted battery alarms present in the event history log.During the functional testing the reported issue was able to be duplicated.The root cause of the reported problem could be due to the normal wear of the battery, but this could not be validated since no expiration date indicated on the battery.Replaced the battery.
Event or Problem Description
It was reported that the pump would not hold a charge unless plugged in.No patient injury was reported.

• Brand Name: MEDFUSION 3500 PUMPS
• 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; 345 n nimitz hwy unit c; minneapolis, MN 55442
• MDR Report Key: 16380620
• Report Number: 3012307300-2023-01291
• Device Sequence Number: 6279207
• Product Code: FRN
• UDI-Device Identifier: 10610586043017
• UDI-Public: 10610586043017
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K040899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2023

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: 02/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• 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