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

Model Number ACT200

Device Problem Incorrect Measurement (1383)

Patient Problems Hemorrhage, Cerebral (1889); Intracranial Hemorrhage (1891)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

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 issue.Blood samples from the patient were analyzed in medtronic's act plus coagulation monitor, however several measurements values were displayed within the normal range, although the patient has already been given heparin and it should have come to a change of the analysis value.Instrument was replaced with a back up and it is reported that this event led to a deterioration in the patients health status.Additional information received: patient suffered from a stroke due to increasing levels of heparin.The used act showed several times an act between 130-150s.Blood samples were drawn from different locations/ports.Due to the results, increasing doses of heparin were given, to the point someone recognized problems with patient.They then used a different act device from a different unit (dialysis) and received a completely different act value.They started regularly quality controls, since they already had a defective act device several months ago.It is unknown how frequently they are performing quality controls and what cartridges or methods they used.

Manufacturer Narrative

The act plus instrument was returned and the reported measurement issue was not verified during service.The service technician could not reproduce the issue.Preventive maintenance will be performed per specifications.Trends for issues with this product are monitored.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.

• Brand Name: ACT PLUS INSTRUMENT
• Type of Device: TIMER, CLOT, AUTOMATED
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 10740981
• MDR Text Key: 213219566
• Report Number: 2184009-2020-00071
• Device Sequence Number: 1
• Product Code: GKN
• UDI-Device Identifier: 00643169178410
• UDI-Public: 00643169178410
• Combination Product (y/n): N
• PMA/PMN Number: K940426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACT200
• Device Catalogue Number: ACT200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR