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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 06/15/2019
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.Multiple attempts were made unable to get information.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
This event was determined to be a duplicate to (b)(4), (b)(4).The manufacturer's investigation conclusion was captured under mfr# 2916596-2019-03291.
 
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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 Key8771196
MDR Text Key150393443
Report Number2916596-2019-03292
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 11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number102956
Device Catalogue Number102956
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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