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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 201-30300
Device Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/10/2019
Event Type  malfunction  
Manufacturer Narrative
The associated centrimag 2nd generation primary console, sn: unknown is reported under mfr # 2916596-2020-00893 and the associated centrimag motor, ous, sn: (b)(4) is reported under mfr # 2916596-2020-00892. The device is expected to be returned for evaluation. It has not yet been received. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported that there was an s3 alert on the console while the system was in use on a patient in an ambulance en-route to the hospital. There was also no flow probe reading. The back-up console was attached and initially got a reading. However, then the same s3 alert appeared and the flow probe did not have a reading. The device was detached from the ambulance power supply and turned off and on. Following that the flow probe worked fine for the duration of the journey. There were no adverse patient effects. 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 Key9748437
MDR Text Key182444429
Report Number2916596-2020-00891
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K131179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-30300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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