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

Model Number ACT100

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the reported issue that the electronic and weekly controls appeared functional but displayed discrepancies in patient processing compared to another instrument, was verified during service.The service technician observed that the actrac drop times value was slightly lower, but within specs.Additionally, the sensor board had blood stains, and dust was present on electronic components.The issues were resolved by cleaning the sensor board, removing dust from electronics and replacing the assy switch softkey act plus, the assy switch kypad act pls, the keypad overlay intl act plus and the overlay softkey intl act plus.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.

Event Description

Medtronic received information that during use of an act plus instrument, it was reported that the electronic and weekly controls are ok but when a patient is processed the customer sees a difference that does not make sense compared to the other machine they have.The customer did an act on a patient and the results were wrong, in the phillips room it was 470 and in the siemens room it was 283.The use of the instrument was unspecified.There was no adverse patient effect associated with this event.

• 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: 19059877
• MDR Text Key: 339669524
• Report Number: 2184009-2024-00154
• Device Sequence Number: 1
• Product Code: GKN
• UDI-Device Identifier: 00643169178380
• UDI-Public: 00643169178380
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2013
• 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