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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
Manufacturer's investigation conclusion: 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, (b)(6) has decided to initiate a voluntary field action for centrimag. (b)(6) performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis. The report of a console's screen going blank was confirmed through the analysis of data log files associated with this complaint. These consoles were evaluated and tested by mcs (b)(4). The first log file was successfully retrieved from 2nd gen primary console (b)(4). Per the log file, at approximately 5:23pm on (b)(6) 2019 an ifd-shutdown (display dark) occurred. Subsequently, voltage errors occurred, followed by system alert:s3 and set pump speed not reached:m5 alerts being triggered on the console. During these events, speed dropped from ~4500rpm and a flow of ~4lpm to a speed of ~3400rpm and flow of 0lpm. Although the console displayed a flow of 0lpm, flow was still available. The reported event was confirmed. The second log file was successfully retrieved from 2nd gen primary console (b)(4). Per the log file, at approximately 7:22am on (b)(6) 2019 an ifd-shutdown (display dark) occurred. Subsequently, voltage errors occurred, followed by system alert:s3 and set pump speed not reached:m5 alerts being triggered on the console. During these events, speed dropped from ~4700rpm and a flow of ~4. 1lpm to a speed of ~3600rpm and flow of 0lpm. Although the console displayed a flow of 0lpm, flow was still available. The exact motor used with each respective console during the events captured in the log files could not be conclusively determined. The investigation of the returned centrimag 2nd gen primary console (serial number (b)(4)) and motor (serial number (b)(4)) was performed by the r&d department of mcs (b)(4). During their investigation, it was found that the console operated as intended. No fault was found with the console. The reported issue was reproduced when the console was tested together with its associated motor (serial number (b)(4)). Further investigation revealed that the motor was responsible for the event observed in the field. Corrective action (capa) was initiated to handle the motor issue and root-cause investigation. Final disposition of the motor will be determined by the capa. 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
It was reported that during animal trials in (b)(6) 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.
 
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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 Key8969539
MDR Text Key161210994
Report Number2916596-2019-04265
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
Reporter Occupation
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 Manufacturer04/09/2019
Is the Reporter a Health Professional?
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? Yes
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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