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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-90401
Device Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/21/2020
Event Type  malfunction  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported that m2-motor disconnected alarm (s/n: (b)(4)) occurred while the patient was moved for a different non-related investigation. The alarm was visually confirmed to have stopped pump function. A perfusionist performed a restart of the pump function with a repeat trial of increasing pump rotations per minute with stable support. A decision was made to perform an elective exchange for a centrimag (cmag) backup unit. During the cmag console exchange, a motor stopped alarm (s/n: (b)(4)) occurred on the new cmag console. The perfusionist decided to use another cmag unit and performed an exchange of the cmag system with a restart of support without any further issue. The patient condition was unchanged. This event is also reported under mfr #3003306248-2020-00006, mfr #3003306248-2020-00007, and mfr #3003306248-2020-00008.
 
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Brand NameCENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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 Key9804756
MDR Text Key189325673
Report Number3003306248-2020-00005
Device Sequence Number1
Product Code DWA
UDI-Device Identifier7640135140689
UDI-Public(01)7640135140689
Combination Product (y/n)N
Reporter Country CodeEZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-90401
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/07/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/31/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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