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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION CENTRIMAG CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC CORPORATION CENTRIMAG CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 201-303000
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/05/2018
Event Type  malfunction  
Event Description
Patient was on venous-venous ecmo using centrimag with oxygenator. The centrimag began alarming pump failure so two rn's emergently switched the device over to the back-up controller. No harm to patient, but high potential for harm.
 
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Brand NameCENTRIMAG
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
15900 valley view court
sylmar CA 91342
MDR Report Key7533443
MDR Text Key108895475
Report Number7533443
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number201-303000
Other Device ID NumberL01940-0005
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/07/2018
Event Location Hospital
Date Report to Manufacturer05/07/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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