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

Model Number	3500
Medical Device Problem Codes	Device Alarm System (1012); Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device exhibited a check syringe plunger sensor error when turned on.It is unknown if there was patient involvement, no adverse patient effects were reported.
Additional Manufacturer Narrative
Other, other text: b3: unknown; no information has been provided to date.One device was returned for evaluation.Visual inspection revealed no appearance of any physical damage.Review of event history logs confirmed the reported check syringe plunger sensor error.Functional testing was able to duplicate the error and revealed the check syringe plunger sensor error occurred intermittently when the plunger assembly was pushed all the way in the side of the device.The root cause of the reported issue was determined to be due to the plunger holders resting on the flange holder when fully retracted, causing "check syringe plunger sensor" error to trigger.Preventative maintenance was performed and the device passed all functional tests with the plunger drive moved out slightly from the pump housing.The products history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• Brand Name: MEDFUSION 3500 PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18042299
• Report Number: 3012307300-2023-10076
• Device Sequence Number: 15319802
• Product Code: FRN
• UDI-Device Identifier: 10610586043017
• UDI-Public: 10610586043017
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2023

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
• Device Catalogue Number: 3500-0600-82
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2018
• 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