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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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THORATEC SWITZERLAND GMBH CENTRIMAG; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 102956
Device Problems Mechanical Problem (1384); No Flow (2991)
Patient Problem No Code Available (3191)
Event Date 06/19/2019
Event Type  Injury  
Event Description
The centrimag console alarmed and was found to have no flow, no rpms.Rns intervened and clamped cannulas and switched out motors and consoles.Pt's maps dropped to 50s but quickly recovered.
 
Event Description
The centrimag console alarmed and was found to have no flow, no rpms.Rns intervened and clamped cannulas and switched out motors and consoles.Pt's maps dropped to 50s but quickly recovered.
 
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Brand Name
CENTRIMAG
Type of Device
CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
6035 stoneridge drive
pleasanton CA 94588
MDR Report Key8831654
MDR Text Key152371340
Report Number8831654
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/19/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number102956
Device Catalogue Number102956
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/19/2019
Event Location Hospital
Date Report to Manufacturer07/26/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/26/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age16060 DA
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