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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

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THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US Back to Search Results
Model Number 102956
Device Problems Insufficient Flow or Under Infusion (2182); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Date 06/16/2019
Event Type  Injury  
Manufacturer Narrative
Multiple attempts were made to obtain patient information however none was provided.Date of event was estimated.Multiple attempts were made to obtain event date, however none was provided.Serial number of the devices was requested but not provided.No further information was provided.A supplemental report will be submitted when the manufacture's investigation is completed.
 
Event Description
It was reported a humming noise was heard from the motor.Centrimag gen 2 monitor showed decreasing flow unresponsive to clinician¿s attempt to increase flow.Flow continued to decrease resulting in patient composition.Patient clamped off ecmo and converted to back up motor.Flow resumed without further issue.
 
Manufacturer Narrative
Section d4: additional information.
 
Manufacturer Narrative
Manufacturer's investigation conclusion: the centrimag motor used during the reported event was not returned for analysis.Multiple attempts for product return were made but the motor was not returned.As a result, the reported event could not be confirmed and the root cause could not be conclusively determined.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual section 3.1.5-"centrimag and pedivas blood pumps" states "the blood flow is dependent upon the amount of blood entering the pump, the pump speed (rpm), the extracorporeal circuit resistance, and drainage and return blood pressures.The relationship between pressure and flow rate as a function of rpm can be seen in figure 16 for a complete centrimag vas circuit (including the pump, tubing, and one representative set of cannulae that may be used with the pump)." this document also has an emergency/troubleshooting section for the 2nd generation console.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 MOTOR, US
Type of Device
CENTRIMAG MOTOR
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ  CH-8005
MDR Report Key8771171
MDR Text Key150391908
Report Number2916596-2019-03291
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 11/06/2019
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 Number102956
Device Catalogue Number102956
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/18/2019
Initial Date FDA Received07/09/2019
Supplement Dates Manufacturer Received08/01/2019
11/06/2019
Supplement Dates FDA Received08/25/2019
11/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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