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	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the reported issue of the instrument not passing quality controls was not verified during service.The field service technician arrived on site and was unable to find any issues with the instrument.The instrument was run through the typical preventive maintenance procedure and everything was within calibration.The service technician used a thermometer to check wells 5 and 6 which were 37.0 degrees celsius.The service technician has advised the facility to try different cartridge lot numbers and the facility has been refer to the clinical specialist.Preventive maintenance was performed per specifications.Note: the instrument was serviced in the field by a medtronic field service technician.The instrument was not returned to a medtronic facility.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that prior to use of a hms plus instrument, it was reported that the system was unable to pass their controls.The site has tried multiple cartridges and different lots with no success.The instrument was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the lot numbers of control cartridges used were: 0231093202, 0231093194, and 0231001774.Quality control is performed on this unit once every 7 days.It was reported that one hms plus instrument had multiple motor stall errors.The other hms analyzers repeatedly failed level 2 quality control.Control values were obtained, but the customer was unsure if they were used.

• 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 ; 091708096
• MDR Report Key: 22282091
• Report Number: 2184009-2025-00778
• Device Sequence Number: 12855558
• Product Code: JOX
• UDI-Device Identifier: 00763000158002
• UDI-Public: 00763000158002
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/18/2025

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: 05/22/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2019
• 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