MAUDE Adverse Event Report: Perfusion Systems HMS Plus Instrument; ANALYZER, HEPARIN, AUTOMATED

Model Number	30514
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of a hms plus instrument, it was reported that it had motor stall error and liquid quality control failures, far right channel issue.The instrument was used.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the lot number of control cartridges used was 0233611731.Quality control was performed for this unit once a week and control values obtained, qc was done after service.
Additional Manufacturer Narrative
Device analysis summary: the reported motor stall error was not verified during service, but the other issue that liquid controls failed was verified during service.Service technician found error code 18, which was a y motor stall error.Customer stated that the y motor keep hitting the cartridge during liquid qc.After examining, service technician found a massive blood drop that was blocking the mylar window from reading the cartridge correctly.The issue was resolved by cleaning the adu.Post-repair preventive maintenance was performed per specifications.Qc was able to fully run and passed the test.Note to d.9: the instrument was serviced in the facility by a field service technician.The instrument was not returned to a medtronic facility for service/analysis.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: HMS Plus Instrument
• Common Device Name: ANALYZER, HEPARIN, AUTOMATED
• Manufacturer (Section D): Perfusion Systems; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): Perfusion Systems; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50867687
• Report Number: 2184009-2026-01398
• Device Sequence Number: 15797631
• Product Code: JOX
• UDI-Device Identifier: 00763000158002
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K111339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 30514
• Device Catalogue Number: 30514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown