MAUDE Adverse Event Report: PERFUSION SYSTEMS ACT PLUS INSTRUMENT; TIMER, CLOT, AUTOMATED

Model Number	ACT200
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of an act plus instrument, it was reported that there were incorrect readings.The use of the instrument was unknown.There was no patient involvement, so no adverse effect occurred.
Additional Manufacturer Narrative
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 lot numbers of the cartridges and controls used are: cartridge 402-03 act-hr lot# 0229910383 expire date: june 9, 2025.The quality control is performed once a year during preventive maintenance (by medtronic fse).No errors were observed associated with this issue.The issue is associated to the expiration of cartridge lot.Additional information d.4 unique identifier (udi) #: this field was updated.Device evaluation summary: the reported incorrect readings issue was verified during service.Service technician observed reported issue while performing quality control (acttrac electronics and clottrac liquid).Service tech found that the used cartridge was expired.Preventive maintenance was performed as per specification.The instrument was serviced/analyzed in the facility by a field service technician.The instrument did not return 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: ACT PLUS INSTRUMENT
• Common Device Name: TIMER, CLOT, 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: 22103216
• Report Number: 2184009-2025-00701
• Device Sequence Number: 15491206
• Product Code: GKN
• UDI-Device Identifier: 00643169178410
• UDI-Public: (01)00643169178410(17)520101(21)ACT2100081
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K940426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: ACT200
• Device Catalogue Number: ACT200
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2022
• 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