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 Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the reported measurement failure was not verified during service, however the service technician noted that there was a blood stain on the lift wire part.The service technician carried out external cleaning and disinfection of the instrument, and periodic replacement of the solenoid for actuator operation.Disassembly and cleaning, inspection work, and calibration work were also carried out.A final operation test was performed and this confirmed that there were no abnormalities.After all the work was completed, the repair / inspection completion label was affixed.Post-repair testing was performed per specifications.Conclusion: the complaint is not confirmed for the act plus instruments reported measurement failure.No patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.No further actions to be taken at this time.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use this act plus instrument had a measurement failure.After confirming the measurement failure, the customer retried the measurement using a new cartridge, but the issue did not improve.The customer stated that they have not measured since then.There were no adverse patient effects as a result of this issue.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12460861
• MDR Text Key: 271057664
• Report Number: 2184009-2021-00079
• Device Sequence Number: 1
• Product Code: GKN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K940426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2021

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
• 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: 05/06/2021
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2012
• 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