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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE Back to Search Results
Model Number 201-90411
Device Problem Visual Prompts will not Clear (2281)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2019
Event Type  Injury  
Event Description
The patient was placed on extracorporeal circulatory support at an unspecified date. It was reported the blood pump was rattling, but still spinning. The console indicated for low flows and a system alert (s3) alarm. The system was switched to a new circuit (console, motor, and flow probe). Pump was working, but there were no flow readings and o rattling sound. The initial system was rebooted and the patient was switched back to initial system. Pump continued to rattle. The pump was then switched to the backup system again and worked properly. There was no adverse impact to the patient during this event. No further information was received.
 
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Brand NameCENTRIMAG 2ND GENERATION PRIMARY CONSOLE
Type of DevicePRIMARY CONSOLE
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 Key8334183
MDR Text Key136618522
Report Number2916596-2019-00675
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 Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-90411
Device Catalogue Number201-90411
Device Lot Number6382423
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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