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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 Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/17/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that after approximately 25 minutes of using this 560 bio-console instrument on battery power, the instrument displayed the battery charge symbol on the user interface. The instrument had been running at approximately 2000-2500 revolutions per minute (rpms) and powered off after approximately 30 minutes. The hand crank was used until the instrument could be plugged into a power source in the ambulance. The hand crank was again used during patient transport into the hospital as there was not sufficient time allowed to recharge the batteries. There were no adverse patient effects associated with this event.
 
Manufacturer Narrative
The reported depleted battery was verified in the field by medtronic service technician. The service technician ran the instrument until the batteries were charged. Further analysis found that the batteries were over five years old. The issue was resolved by replacing the batteries. Final testing was performed per specification. The device history record was reviewed to show that the instrument passed all in-process inspections and tests. No abnormalities were noted during the manufacture of this instrument. Batteries are to be replaced every four years per the preventive maintenance schedule. A review of complaint and service records for june 2012 to april 2017 associated with this instrument found no other instances of battery replacement. A review of complaints identified no current trends.
 
Event Description
Medtronic received information that during use of this 560 bio console instrument the instrument powered off and a hand crank was used until the instrument could be plugged into power source. The hand crank was again used during patient transport as there was not sufficient time allowed to recharge the batteries. There were no adverse patient effects associated with this event.
 
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Brand NameBIO CONSOLE 560
Type of DeviceCONTROL, 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
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key6564651
MDR Text Key101858690
Report Number2184009-2017-00018
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/29/2013
Device Model Number560BCS1
Device Catalogue Number560BCS1
Was Device Available for Evaluation? No
Date Returned to Manufacturer04/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/12/2017 Patient Sequence Number: 1
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