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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 560BCS1
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2024
Event Type  malfunction  
Event Description
Medtronic received information that at an unspecified time, this bio-console instrument had an error 25 (sc mpu fs coil driver monitor low hard error).The use of the instrument was unspecified.There was no adverse patient effect reported with this event.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
Device evaluation summary: the reported issue that this bio-console instrument had an error 25 was not verified during service.The service technician found no errors in the log file, also no errors occurred when the instrument was being operated.The back-up batteries did not charge anymore and the instrument shut down within a few seconds when the power outlet has been disconnected.It was also observed that the charging circuit on the system controller did not charge correctly.The issues were resolved by cleaning the instrument and replacing the hw, screw, 8, ph, pl, ss, 1.0, the assy system controller module -006 and the battery ,12v,6.5 ah,certified.Preventive 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.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 Key19059277
MDR Text Key340472632
Report Number2184009-2024-00153
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K080824
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,Followup
Report Date 05/24/2024
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 Number560BCS1
Device Catalogue Number560BCS1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/12/2024
Initial Date FDA Received04/08/2024
Supplement Dates Manufacturer Received05/14/2024
Supplement Dates FDA Received05/24/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2014
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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