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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 Problems Battery Problem (2885); Power Problem (3010)
Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Ischemia (1942); Cardiovascular Insufficiency (4445)
Event Date 03/21/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use of this bio-console instrument the backup battery was unreliable and the power output time did not match the nominal power in the manual. Due to acute large-area myocardial infarction, the patient needed to use ecmo to replace the heart function in order to be transferred from the other hospital to this hospital for treatment. The ecmo team at the facility received a request from (b)(6) hospital to implement ecmo treatment on the afternoon of march 21. The team members set out after checking the materials and equipment. At 20:00, the pre-inflation was completed when the instrument was using ac power, and the reserve battery showed green full power. At 20:30, the patient's arteriovenous cannula insertion was completed, and then the patient was successfully connected and the instrument started to turn. The centrifugal pump speed was set to 2730 r/min and the flow rate was 2. 93l/min. After observation for a period of time, the patient¿s vital signs met the requirements for transfer, the ac power was disconnected at 20:58, the reserve power was activated, and battery display was full. The team members worked in cooperation with a due division of labor to carry the patient and equipment to the ambulance on standby downstairs, at approximately 21:05, it was found that the reserve power was yellow with 8 cells, and it was prompted that the power was insufficient. After that, the power dropped rapidly. Before the transfer to the ambulance at 21:13, there was only one cell on the battery icon, and then it was automatically turned off. The patient¿s heart rate dropped from the original 110 beats/min to heart rate 75 beats/min, blood oxygen saturation dropped from the original 98% to 88%. The medical staff immediately removed the centrifugal pump head and replaced it with the hand pump and manually maintained the centrifugation pump. After rescue, the patient¿s vital signs improved, with heart rate 95 beats/min, blood pressure 95/52mmhg, blood oxygen saturation 95%. After that, the equipment and the patient were loaded into the ambulance with the use of a hand pump, and the ac power on the ambulance was connected. After the ecmo was able to operate normally, they returned to the hospital immediately. They arrived at this hospital at 22:00, and after the patient and the equipment were removed from the ambulance, the power of ecmo equipment was still insufficient to reach the department. After they entered the elevator, it had been maintained by a hand pump. The ecmo could not be connected to ac power until the patient reached the catheterization room. The operation was successfully completed and the patient returned to the ward.
 
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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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key12324137
MDR Text Key266635932
Report Number2184009-2021-00070
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K080824
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number560BCS1
Device Catalogue Number560BCS1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2020
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: 08/16/2021 Patient Sequence Number: 1
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