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U.S. Department of Health and Human Services

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

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THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR MOTOR, RENTAL Back to Search Results
Model Number L102956
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Patient Involvement (2645)
Event Date 02/27/2019
Event Type  Injury  
Manufacturer Narrative
Manufacturer investigation conclusion: the reported event of a s3 alarm was confirmed via the log file. The centrimag motor was returned to mcs (b)(4) for analysis and was investigated by (b)(4). The reported event of a s3 alarm was able to be confirmed via the log file; however, it was not able to be reproduced. A log file was downloaded from the associated and returned console. A review of the downloaded log file showed an ifd-shutdown (display dark) sub fault active on (b)(6) 2019 at 05:01. The sub fault triggered a ¿system alert: s3¿ and a ¿set pump speed not reached: m5¿ alarms. The speed dropped from 4300 rpm (flow of 3. 8 lpm) to 3420 rpm with 0 lpm of flow displayed. A further investigation on the returned devices was performed by the r&d department of mcs (b)(4). Although the reported event could not be reproduced, reports of similar events have been documented and corrective action had been initiated to investigate the issue. The investigation has determined that this event was caused by a motor related issue. The motor was forwarded to mcs (b)(4) and was evaluated and tested. The motor was connected to a test console, pump, and mock loop. The motor was able to support the pump at the set speed without any issues. The reported event was not reproduced during testing. 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 no further information was provided. The manufacturer is closing the file on this event.
 
Event Description
No patient was involved with the centrimag ventricular assist device. It was reported that the account noted an s3 alarm. The account sent back the motor and console for service and evaluation. The alarm occurred during set-up prime.
 
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Brand NameCENTRIMAG MOTOR
Type of DeviceMOTOR, RENTAL
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 Key8969998
MDR Text Key156766781
Report Number2916596-2019-04247
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 company representative,health
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 NumberL102956
Device Catalogue NumberL102956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2019
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 Manufactured04/23/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberFA-Q319-MCS-1

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