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	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of an act plus instrument , the customer reported that they were experiencing premature stoppage of channel 2 during test runs, described in detail below: during testing, channel 2 consistently stopped earlier than expected.Test 1: channel 1 finished at 282 seconds and channel 2 at 124 seconds, indicating a a channel variance greater than 12%.Test 2: channel 2 stopped at 25 seconds.The test was terminated at 37 seconds for channel 1 upon realizing the premature stoppage.Test 3 (approximately 45 minutes later): the same patient was tested again, with channel 2 stopping at 63 seconds and channel 1 at 279 seconds.After noticing the issue, the lab personnel were instructed to thoroughly clean the system before its next use.The customer cleaned and tested the system, they ran a series of acttrac, temperature verification, two abnormal, and two normal car tridges, totaling four tests. all abnormal test results came back acceptable. one normal test indicated a channel variance grater than 12%, with channel 1 stopping early.Despite adhering to the correct testing process, the customer expressed concerns over a potential issue with the instrument itself. the instrument was used to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the patient had heparin administered based on the results obtained from acceptable values (no error codes) on this instrument and another instrument that was used when this instrument was giving the erroneous readings.Medtronic received additional information that the test results obtained were not from a replacement instrument.They were from the same instrument, post a second attempt to repair the device.Channel 2 was working intermittently and would in some instances provide results, but they were out of spec.
Additional Manufacturer Narrative
Device evaluation summary: the reported channel variance grater than 12% was verified during service.The issue was resolved by replacing the flag motor assy.Preventive maintenance 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 ; 091708096
• MDR Report Key: 19382103
• Report Number: 2184009-2024-00311
• Device Sequence Number: 14395340
• Product Code: GKN
• UDI-Device Identifier: 00643169178380
• UDI-Public: 00643169178380
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 05/23/2024

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: 04/24/2024
• Initial Report FDA Received Date: 05/23/2024
• Date Device Manufactured: 05/15/2020
• 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