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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-90411
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/04/2021
Event Type  malfunction  
Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
 
Event Description
It was reported that the patient was placed on circulatory mechanical support due to severe hypoxemia due to sarscov 2.The patient was in a very critical condition due to their pathology.Upon issuing the centrimag there was a m4 alarm and after 30-40 seconds the motor stopped.The patient was immediately switched to the backup motor.The patient did not present any complications from this event.Related manufacturer report number 3003306248-2021-04012.
 
Manufacturer Narrative
Manufacturer's investigation conclusion: the centrimag console was evaluated due to the reported event of an m4: motor alarm.However, the centrimag console was not returned for analysis, and no log files were associated with the reported event.The root cause of the reported event was determined to have been an issue with the returned centrimag motor (serial number (b)(6) ) and has been addressed via the motor¿s investigation.The serial number of the centrimag console was not provided.The 2nd generation centrimag system operating manual provides information regarding emergencies/troubleshooting in section 10.The recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.No further information was provided.The manufacturer is closing the file on this event.
 
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Brand Name
CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
Type of Device
CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ  CH-8005
Manufacturer (Section G)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ   CH-8005
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key12290182
MDR Text Key265576790
Report Number3003306248-2021-04013
Device Sequence Number1
Product Code DWA
UDI-Device Identifier07640135140702
UDI-Public7640135140702
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K131179
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 12/27/2021
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 Number201-90411
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/08/2021
Initial Date FDA Received08/06/2021
Supplement Dates Manufacturer Received12/17/2021
Supplement Dates FDA Received12/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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