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

Model Number ACT100

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/15/2023

Event Type  malfunction  

Event Description

Medtronic received information that during use of an act plus instrument, it was reported that the results of the act did not fit the clinical situation, the customer thought that the results should be higher.A patient bled a lot, with measurement of 263 act, was compared to competitors device, which showed 366 act.The customer tried to check the calibration of the act device with the acttrac¿ electronic control for act plus , the control failed. the instrument was replaced to complete the procedure.There was no lasting patient impact associated with this event.Medtronic received additional information that the acttrac quality control is preformed every day.There was no error code associated with this issue observed.The customer stated that test results were obtained, and heparin was administered based on the results.The customer could not inform us how much blood was lost.The customer resolved the patients blood loss by putting pressure on the blood vessel.From customer point of view the adding pressure on the vessel was not intervention.

Manufacturer Narrative

Device evaluation: the reported wrong results on testing was not verified during service.The service technician found leftovers from the swab glowing with blood to the sensor in the flag pcb.The service technician measured temperature: 37.0 degrees celsius.The issue was resolved by cleaning the device.The service technician cleared statistic log file (no serious errors).The lift wire height: 0.0930-0.0930-inch, results were o.K.The service technician performed acttrac cartridge test 99-99 sec, (range 98-102 sec) results o.K.The service technician performed test according procedure 31598 revision 1c, results o.K., performed electrical safety test, results o.K., performed test with clottrac hr normal coagulation controls and deionized water.Post-repair testing was performed per specifications.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 16362158
• MDR Text Key: 309980725
• Report Number: 2184009-2023-00080
• Device Sequence Number: 1
• Product Code: GKN
• UDI-Device Identifier: 00643169178380
• UDI-Public: 00643169178380
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 02/13/2023

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: 01/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2023
• Initial Date FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2018
• 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