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

Model Number	ACT100
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the reported issue that the act plus instrument failed the quality control test (qc) test 3 times was not verified during service.The service technician called for further information, customer stated that the tag on the unit simply stated that the unit failed qc.It was requested which qc with no details available.Asked the customer to run actrac (electronic qc) with qc passing.Customer stated they would still like for the service technician to come in and look at the machine and perform a pm.Field service: the service technician spoke with perfusion team while on site and they could not provide with cartridge or controls lots used in the test or if they used a different lot for the second or third tests.The service technician performed liquid qc and tests in accordance with all applicable maintenance instructions and manuals with all checks checking within limits.Preventive maintenance was performed per specifications.Note the instrument was not returned to medtronic facility but was serviced by field service technician.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 during use of an act plus instrument, the customer reported that it failed the quality control ( qc) test 3 times.The use of the instrument was asked but unknown.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Additional info b5: medtronic received additional information that electronic quality control performed for this unit every 8 hours, and liquid controls is performed weekly.There was no error code associated with this issue, and no test results obtained.Correction to additional codes: updated the fdp and imf codes correction a1: updated patient identifier 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: 19740391
• Report Number: 2184009-2024-00408
• Device Sequence Number: 3689758
• Product Code: GKN
• UDI-Device Identifier: 00643169178380
• UDI-Public: 00643169178380
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K940426
• 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,Followup
• Report Date (Section B): 07/19/2024

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: ACT100
• Device Catalogue Number: ACT100
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2020
• 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