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

Model Number ACT100

Device Problems Device Alarm System (1012); Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the reported bad reference in channel 2 issue was verified during service.The service technician observed that the lift wire motor was not parking properly and they found light path errors in the error log.The issue was resolved by replacing the assy flag sensor and flag motor.Preventive maintenance was performed as per specification.Note: the instrument was serviced within the facility by a medtronic field service technician.The instrument did not return to a medtronic facility for service.Conclusion: after investigation the complaint is confirmed for the act plus instrument¿s bad reference in channel 2.The issue was verified during service.No patient/clinical safety issues were reported.Trends for issues with this product are reviewed at quarterly quality meetings.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that prior to use of an act plus instrument, it was reported that the instrument had a bad reference for channel 2.The instrument was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that there was an error code for light path error.The test results were not obtained, as the device was out of service due to issue with quality controls (qcs).

• Brand Name: ACT PLUS INSTRUMENT
• Type of Device: 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: 16990816
• MDR Text Key: 315829802
• Report Number: 2184009-2023-00321
• Device Sequence Number: 1
• Product Code: GKN
• UDI-Device Identifier: 00643169178380
• UDI-Public: 00643169178380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACT100
• Device Catalogue Number: ACT100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1