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

Model Number ACT200

Device Problems Electrical /Electronic Property Problem (1198); Temperature Problem (3022)

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

Event Date 03/26/2024

Event Type  malfunction  

Event Description

Medtronic received information that prior to use of an act plus instrument, it was reported that the reading value was too high.The use of the instrument was unknown.There was no patient involvement, so no adverse effect occurred.

Manufacturer Narrative

Device evaluation summary: the reported issue that the reading value was too high was verified during service.The issue was resolved by resetting all the electrical connections and cleaning the heater block and sensors.Service technician tested the act plus with act trac and hr act cartridge and instrument was in working good condition.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.

Manufacturer Narrative

Medtronic received additional information that the left side channel readings were too high.The lot numbers of cartridges and/or controls used are unavailable.Both liquid and electronic (acttrac or heptrac) controls were used.The quality control is performed for this unit every half a year.There was no error codes associated with this report.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
• 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: 19096365
• MDR Text Key: 340123285
• Report Number: 2184009-2024-00182
• Device Sequence Number: 1
• Product Code: GKN
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K940426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACT200
• Device Catalogue Number: ACT200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2010
• 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