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

Model Number ACT100

Device Problem Mechanical Problem (1384)

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

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

Analysis and investigation - the complaint is not confirmed for the act plus instruments reported erroneous readings.The reported erroneous readings issue was not verified during service.Service technician performed testing and verification of instrument and found flag height out of tolerance due to mounting screw at base of flags not secure.Tightened set screw and flag height was still out of limits, adjusted flag height adjustment set screw and could not bring flags into consistent tolerances due to flag motor sensor causing the stop of the flags at the peak of a stop.Adjusted flag position sensor, adjusted flag height to within tolerances, performed performance checks and witnessed liquid controls against this instrument and a secondary instrument, with all checks testing within limits.The cartridge for controls were from the same lot and utilized the same control for both instruments, readings for abnormal were only a 3 seconds from each other on both.Trends for issues with this product are reviewed at quarterly quality meetings.The act plus software constantly monitors for software and/or hardware faults.When one is found, an error is displayed and typically addressed by the operator.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of this act plus instrument the customer was suspicious of the readings during a case and had them compared to another two instrument and found this instrument to be intermittently erroneous.The customer tried the instrument with same and different cartridge lots but changing the cartridge lot did not resolve the issue.The instrument was changed out with a backup and there was no resulting adverse patient effect.

• 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: 11906694
• MDR Text Key: 264946218
• Report Number: 2184009-2021-00046
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/31/2021

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: 05/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 05/31/2021
• Date Device Manufactured: 08/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1