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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-90411
Device Problem Decreased Pump Speed (1500)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/27/2019
Event Type  Injury  
Manufacturer Narrative
This event was also reported against the motor under mfr. Report # 2916596-2019-05221. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported there was an error message stating the system was unable to reach speed. It was reported that there was suspicion the centrimag motor may fail so necessary equipment was gathered to change to the backup system. A few minutes later the motor failed with an audible alarm and a red error message. The motor and console were exchanged in about 1 minute without incident. No further information was provided.
 
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Brand NameCENTRIMAG 2ND GENERATION PRIMARY CONSOLE
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 Key9324468
MDR Text Key166519755
Report Number2916596-2019-05222
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Model Number201-90411
Device Catalogue Number201-90411
Device Lot Number6818905
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/30/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/13/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/14/2019 Patient Sequence Number: 1
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