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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 ADULT FLOW PROBE, CAN CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH ADULT FLOW PROBE, CAN CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-90421
Device Problem Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 04/26/2019
Event Type  Injury  
Manufacturer Narrative
It was reported no patient was involved in this event. No further information was provided. A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
It was reported abbott technical services received a call stating centrimag primary console l01769-0006 received a b1 (system alert- battery module failure) alarm. Upon further investigation and testing the unit then received an s1 (power on test fail) alarm. A battery maintenance test was performed and the unit passed. The customer confirmed the unit¿s batteries were recently replaced a few months prior. The alarms have not been able to be replicated on the unit. The unit has been testing on a mock loop. It was reported no patient was involved in the event. Additional information has been requested but has not yet been provided.
 
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Brand NameCENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH ADULT FLOW PROBE, CAN
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 Key8601742
MDR Text Key144796717
Report Number2916596-2019-02303
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-90421
Device Catalogue Number201-90421
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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