• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PERFUSION SYSTEMS; TIMER, CLOT, AUTOMATED Back to Search Results
Model Number RACT200
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2021
Event Type  malfunction  
Manufacturer Narrative
Device evaluation summary: the reported difference in ch1 and ch2 value issue was not verified during service.Service technician found no defect, but did observed error codes 010, 012 and 015 (routine errors) in the statistic log file, and blood accumulation on the actuator.The instrument was cleaned, statistic log file cleared (no serious error).Preventive maintenance was performed as per specification.Conclusion: the complaint is not confirmed for the act plus instruments reported different countings on ch1 and ch2.No patient/clinical safety issues reported.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.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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.
 
Event Description
Medtronic received information that at an unspecified time this act plus instrument had a defect in the registration section.It was noted that there were different countings on ch1 and ch2, a big difference in values.Use of the instrument was unspecified.There was no patient involvement so no adverse event occurred.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key17237069
MDR Text Key318341379
Report Number2184009-2023-00688
Device Sequence Number1
Product Code GKN
Combination Product (y/n)N
Reporter Country CodeBU
PMA/PMN Number
K940426
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/30/2023
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 NumberRACT200
Device Catalogue NumberRACT200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/08/2021
Initial Date FDA Received06/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-