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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 Problems Decreased Pump Speed (1500); Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/25/2019
Event Type  Injury  
Manufacturer Narrative
Patient age was not provided. Patient weight was not provided. Approximate age of device - can not be determined. The patient remains ongoing with the device. No further information was provided. A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
The patient was implanted with a left ventricular assist device (lvad). The date of implant is not known. It was reported the patient was being supported by centrimag and the nursing staff noticed a dash dash dash on the flow and the speed automatically reduced from 4200 rpms to 3000 rpms to 2000 rpms to 1000 rpms. Perfusion was called & the console & motor was changed to the backup. Patient was back supported without incident.
 
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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 CA CH-80 05
SZ CH-8005
Manufacturer (Section G)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CA CH-80 05
SZ CH-8005
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key8420090
MDR Text Key138771772
Report Number2916596-2019-01206
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 Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 03/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Model Number201-90411
Device Catalogue Number201-90411
Device Lot Number6073461
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/05/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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