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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS CONSOLE 560BC1 CONTROLLER W/O SAFETY BRD CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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PERFUSION SYSTEMS CONSOLE 560BC1 CONTROLLER W/O SAFETY BRD CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 560BC1
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/11/2017
Event Type  Injury  
Manufacturer Narrative
The report of the bio-console¿s audible alarm was confirmed and resolved under a similar report by replacement of the user interface controller board and the bitsy xb computer module. In this occurrence, the customer stated the safety system settings were changed on the bio-console without the perfusionist¿s knowledge. Chapter 6 of the operator and reference manual (instructions for use) addresses the safety systems and includes the caution statement ¿the performance of the safety systems must be verified before each use. ¿ a clinical review of this event concluded: the outcome of this event was compounded by the user being unaware of the level sensing system response settings during the case. There are no new risks associated with the use of the bio-console 560 as no new failure modes or use conditions of the system have been observed. A review of bio-console 560 complaints received from (b)(6) 2012 through (b)(6) 2018 was conducted; the observed field performance is aligned with the predicted field performance. The operator¿s manual instructs the user to verify the safety systems will respond appropriately prior to each use and provides instructions for verifying the safety systems. No additional actions necessary. All reported complaints for this product are monitored and trended. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The product has not been returned for analysis and no definitive conclusions can be made regarding the root cause of the clinical observation. Medtronic's investigation is in process. 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 during a bypass procedure the low blood level alarm on the bio-console was triggered when the level sensor detached from the side of the blood reservoir. The low blood level alarm on the instrument was set to ¿stop¿, which halted the centrifugal pump and positive flow of blood within the perfusion circuit. The perfusionist stated that the settings on the instrument would normally be set to trigger an audible alert and a change to ¿coast¿ mode (2,000 rpm) instead of ¿stop", but they had been changed without the users knowledge. As the perfusionist turned the rpm control knob to zero to reset the instrument and reinitiate flow, they observed that there was -0. 4 l/min. Of backflow. The user estimated that this period of backflow continued for 30 seconds. The aortic root and left ventricular vents were activated, which entrained air into the circuit from the surgical field. While intraoperative transesophageal echocardiography (tee) did not verify intracardiac air, the patient subsequently developed an episode of ventricular fibrillation. The patient was put into deep trendelenburg for approximately thirty minutes while keeping the mean arterial pressure (map) in the eighties. The cerebral saturation, which had dipped to 20 on the right side and 30 on the left side, increased with the resumption of flow to levels observed prior to the event. The patient was successfully weaned from bypass. Post-operative ct scans confirmed that there was no evidence of neurologic injury related to air embolism.
 
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Brand NameCONSOLE 560BC1 CONTROLLER W/O SAFETY BRD
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 Key7051030
MDR Text Key104530794
Report Number2184009-2017-00044
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,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number560BC1
Device Catalogue Number560BC1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/22/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/21/2017 Patient Sequence Number: 1
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