Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 BIO CONSOLE 560; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
  • 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 BIO CONSOLE 560; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 560BCS1
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/21/2014
Event Type  malfunction  
Event Description
Medtronic received information that at first start-up of this 560 bio-console, the user noticed that error codes were present.The console was shut down and restarted, and afterward there were no errors present.The user then started the prime procedure, and for ~10 to 15 minutes, with the unit running at a very low speed, no issues were observed.When the user attempted to raise the speed by a small amount (set point was lower than 2000 revolutions per minute) the external motor speed rose to the maximum level.It was not possible to reduce the speed, so the customer replaced the bio-console 560 with a bio-console 550 and was then able to perform the procedure.It was reported that use of the external drive motor continued; it was only the bio-console that was replaced.There were no adverse patient effects as a result of the event.
 
Event Description
Medtronic received information that at first start-up of this 560 bio-console, the user noticed that error codes were present.The console was shut down and restarted, and afterward there were no errors present.The user then started the prime procedure, and for ~10 to 15 minutes, with the unit running at a very low speed, no issues were observed.When the user attempted to raise the speed by a small amount (set point was lower than 2000 revolutions per minute) the external motor speed rose to the maximum level.It was not possible to reduce the speed, so the customer replaced the bio-console 560 with a bio-console 550 and was then able to perform the procedure.It was reported that use of the external drive motor continued; it was only the bio-console that was replaced.There were no adverse patient effects as a result of the event.
 
Manufacturer Narrative
Onsite instrument inspection by (b)(4) technical service (ts) was unable to reproduce the reported motor speed issue.The unit was then taken to the medtronic ts engineer's workshop for additional testing and service.As a preventative measure, the technical service representative replaced the system controller circuit board, flow/pressure circuit board, internal user interface cable, and external motor.A software upgrade was also performed.The error and the event log file for the instrument was provided to the (b)(4) for additional analysis and investigation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Manufacturer Narrative
Review of the 560 bio-console data log confirmed the occurrence of the reported event; however, the technical service engineer was unable to duplicate the reported issue during testing of the instrument.Based upon the information provided, the investigation concluded the event appeared to have been caused by an intermittent function of the hall effect sensor or related parts.However, since the issue could not be duplicated, the root cause could not be confirmed.As such, all related components were replaced by the technical service engineer to resolve the issue.The instrument was tested after the replacements were made and performed according to specifications.Clarification: in the previous report filed for this event, one of the circuit boards that were replaced as a precautionary measure was described as the flow/pressure printed circuit board.Additional information has been received from the field service technician clarifying that it was the motion/pressure printed circuit board that was changed.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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)
MEDTRONIC STRUCTURAL HEART
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key3875344
MDR Text Key4460870
Report Number2184009-2014-00043
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K070286
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 07/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/09/2012
Device Model Number560BCS1
Device Catalogue Number560BCS1
Was Device Available for Evaluation? No
Date Returned to Manufacturer05/26/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/08/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-