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	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to use of the hms plus instruments it was noted that the instruments were failing flag height and receiving abnormal quality control results.The same results were observed when using three different cartridges and instruments.The instruments were used to complete the procedure.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Device evaluation summary: the reported issue that the instrument was failing flag height and receiving abnormal quality control results was verified during service.The service technician noted that the flag height was too high and the dispensing levels were out of limits.The issue was resolved by adjusting the flag height to within limits and adjusting the syringe switch to the proper dispensing levels.Preventive maintenance was performed per specifications.The instrument was analyzed/serviced in the facility by a field service technician.The instrument did not return to a medtronic facility for analysis/service.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.
Additional Manufacturer Narrative
Medtronic received additional information that both liquids failed.Quality control is performed for this instruments as prescribed by medtronic.There was no error code associated with this issue.No control values obtained.Additional information d4 unique identifier (udi) #: this field was updated.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.
Additional Manufacturer Narrative
Medtronic received additional information that the issue was only with two instruments.The second instrument was reported separately and has its own case and service report.The third instrument mentioned underwent preventive maintenance, and no issues were found, therefore, it is not a complaint.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 ; 091708096
• MDR Report Key: 22182647
• Report Number: 2184009-2025-00743
• Device Sequence Number: 8617420
• Product Code: JOX
• UDI-Device Identifier: 00673978698793
• UDI-Public: (01)00673978698793(11)180910(21)9002714
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2025

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: 05/12/2025
• Supplement Date Received by Manufacturer: 06/12/2025; 07/07/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/07/2025; 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2018
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown