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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

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THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US Back to Search Results
Model Number 102956
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Patient Involvement (2645)
Event Date 01/15/2019
Event Type  Injury  
Manufacturer Narrative
Approximate age of device 6 months 6 days. The device returned for analysis. The complaint investigation determined the reported event was the result of a software design related issue. After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag. Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis. Manufacturer's investigation conclusion: the reported event could not be confirmed nor reproduced during testing of the returned centrimag motor (serial number (b)(4)). The motor was evaluated and tested by tech service. The reported complaint could not be duplicated during the investigation. The motor was tested for an extended period of time with its related centrimag 2nd gen console. The motor was operated at different speeds and flow rates without any flow issues or atypical alarms being reproduced. The motor's cable was inspected and no issues were observed. The motor was then functionally tested per the centrimag motor service process and the unit passed all tests. The returned motor was found to function as intended. As a result, the root cause of the reported event could not be conclusively determined nor correlated to the returned motor. The tested motor was returned to the customer site. Reports of similar events will continue to be tracked and monitored. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
The patient was being supported by an extra corporeal circulatory support pump or acute biventricular extra corporeal circulatory support. It was reported that during animal trials in atlanta there was an issue with centrimag hardware. A console's screen went blank; the motor continued to run, however the user had to swap the console and motor onto a backup. The console and motor were both returned for evaluation. No additional information was reported. This event was previously not reported because there were no allegations of cmag motor issues identified. Abbott made the decision on (b)(6) 2019 to initiate a voluntary recall, therefore, this event is being upgraded to reportable.
 
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Brand NameCENTRIMAG MOTOR, US
Type of DeviceCENTRIMAG MOTOR
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 Key8969659
MDR Text Key156749955
Report Number2916596-2019-04269
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
Remedial Action Recall
Type of Report Initial
Report Date 09/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number102956
Device Catalogue Number102956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberFA-Q319-MCS-1

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