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	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the reported issue that the instrument was increasingly producing incorrect measurements.Either only one chamber was being measured, or the act stopped after a few seconds, or the chambers had a very high time difference was not verified during service.Service technician could not reproduce reason for return.Errors found in statistic log file: 010, 012, 013 and 015 (routine errors).Service technician observed internal dust and blood accumulation on lift bar and flag sensor.This issue was resolved by cleaning the instrument.Service technician performed verify clamping fastener in lift drive assembly and replaced screw lift drive assembly.Service technician adjusted lift bar height to 0.0920-0.0915 inch.Service technician performed several tests with water, results o.K.Service technician performed cartridge test hr-nm 92.0-92.0 sec, (range 072-112 sec) and hr-ab 303-309 sec, (range 267-559 sec), results o.K.Cleared statistic log file (no serious error).Preventive maintenance was performed per specifications.Note: 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.
Event or Problem Description
Medtronic received information that at an unspecified time, this act plus instrument was increasingly producing incorrect measurements.Either only one chamber was being measured, or the act stopped after a few seconds, or the chambers had a very high time difference.The use of the instrument was unspecified.There was no adverse patient effect reported with this event.

• 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: 23300669
• Report Number: 2184009-2025-01323
• Device Sequence Number: 4864200
• Product Code: GKN
• UDI-Device Identifier: 00643169178410
• UDI-Public: (01)00643169178410(11)130208
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K940426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 02/08/2013
• 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