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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO CONSOLE 560; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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PERFUSION SYSTEMS BIO CONSOLE 560; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 560BCS
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2024
Event Type  malfunction  
Manufacturer Narrative
Device evaluation summary: the reported errors 19, 37 and 21 on screen after power on was verified during service.Error 19, 37 and 21 are related to the fs module and flow probe.User was not able to provide the tx50 flow probe that was used with the 560 base when the error occurred.Service technician was unable to reproduce the reported error and no active errors occurred during inspection or testing.Service technician notified the customer that the tx50 flow probe may have caused the errors.560 base was tested with tx50 flow probe.Preventative maintenance was performed per specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
Medtronic received information that prior to use of a bio-console 560 instrument, it was reported that there were errors 19, 37 and 21 on screen after power on.The instrument was replaced.There was no patient involvement, so no adverse effect occurred.
 
Manufacturer Narrative
Correction h5 (label for single use) and h8 (usage of device): these fields have been updated.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
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Brand Name
BIO CONSOLE 560
Type of Device
CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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 Key19086901
MDR Text Key340583709
Report Number2184009-2024-00176
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070286
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/20/2024
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 Number560BCS
Device Catalogue Number560BCS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/21/2024
Initial Date FDA Received04/11/2024
Supplement Dates Manufacturer Received05/20/2024
Supplement Dates FDA Received05/20/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/02/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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