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	07/15/2026
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 it was giving inconsistent readings.The use of the instrument was unspecified.There was no patient impact associated with the event.Medtronic received additional information that the readings were impossible given the clinical picture of the patient and when the c ustomer swapped for another act machine the results were drastically different.
Additional Manufacturer Narrative
Device evaluation summary: the reported issue that the instrument was giving inconsistent readings was not verified during service.Service technician successfully performed acttrac testing multiple times and the instrument was giving the same results (99s for 98-102s, 497s for 490-510s).Service technician also observed the error code only shows bad references, no flags and test aborted errors.However, a crack was observed in the front top housing of the unit.The issue was resolved by replacing the front housing, overlays, keypad and softkeys, cleaning the lift bar, flag sensor board, and the heat block with cleaning solution and adjusting the lift bar height as it was out of threshold.Post-repair testing was performed per specifications.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 ; +353(091)708096
• MDR Report Key: 50221166
• Report Number: 2184009-2026-01279
• Device Sequence Number: 16031188
• Product Code: GKN
• UDI-Device Identifier: 00643169178410
• UDI-Public: (01)00643169178410(11)131213
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: ACT200
• Device Catalogue Number: ACT200
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2013
• 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