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

Model Number ACT100

Device Problems Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198)

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

Event Date 02/02/2022

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the reported measurement issue was not verified during service.Technician noted upon acceptance, no abnormalities were observed in the current operation.No repair on instrument was required as no issue was detected.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of an act plus instrument, the customer reported one (left) of the measured value (2 channels) was not displayed.The device was used to complete the procedure.There was no patient impact associated with this event.Additional information received reported that, the instrument was operable and as one of the measurement value isn't being displayed the other displayed value was used as the measured value.It is unknown whether heparin was administrated.The lot numbers of control cartridges used is 13393270, there were no liquid or electronic (acttrac) controls used.Quality control was performed in september 2021.There was no report of an error code being displayed, and it was asked but is unavailable if control values were obtained.

• 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: 13631302
• MDR Text Key: 286769117
• Report Number: 2184009-2022-00021
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2022

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 Expiration Date: 01/28/2014
• Device Model Number: ACT100
• Device Catalogue Number: ACT100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 03/01/2022
• Date Device Manufactured: 04/03/2012
• 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