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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 EM-TEC ADULT FLOW PROBE, OUS; PRIMARY CONSOLE WITH ADULT FLOW PROBE

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS; PRIMARY CONSOLE WITH ADULT FLOW PROBE Back to Search Results
Model Number 201-90401
Device Problem Pumping Stopped (1503)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2018
Event Type  malfunction  
Manufacturer Narrative
This medwatch is reporting the primary console.The motor is reported under medwatch mfr report # 2916596-2018-05625.The event occurred at (b)(6).No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
The patient was placed on extracorporeal membrane oxygenation (ecmo) support.It was reported that the pump suddenly stopped working.The healthcare professionals were able to get it to work again without having to exchange any equipment.The patient was not harmed or injured due to event.The patient remains stable on ecmo support.No additional information was provided.
 
Manufacturer Narrative
Manufacturer's investigation conclusions: the reported event could not be confirmed and a root cause could not conclusively be determined through this evaluation.The centimag primary console operating manual states the recommended practice, whenever there is a console or motor malfunction, is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood-pump in the back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support and, then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.No further information was provided.The manufacturer is closing the file on this event.
 
Manufacturer Narrative
Section d10: additional information.Updated manufacturer's investigation conclusions: the reported event could not be confirmed through the evaluation of the returned centrimag console and a specific cause for the event could not conclusively be determined.After receipt, the returned console was cleaned and disinfected.A test monitor was then connected to the returned console, and the console was connected to a mains supply.The log file was then downloaded and analyzed.According to the images attached in to the complaint, the event occurred on (b)(6)2018; however, the log file analysis showed that the data from the event date was already overwritten.The data was then downloaded off the monitor; however, the data from the event date was also overwritten.During the investigation of the returned console, the reported faults could not be reproduced.The returned console and motor was operated together to try to reproduce the reported motor problem.During operation, the motor¿s cable was slightly bent bi-directionally in order to find out if a possible cable break or short circuit would occur.The motor operated as intended during the test and no shorts were reproduced.The system was operating a 3600 rpm with 3.3 lpm flow for 2 days and no errors or issues occurred.The returned console was sent back to the distribution center.The review of the returned console's dhr revealed that the device passed all inspection and tests before being shipped to the distributor.No further information was provided.The manufacturer is closing the file on this event.
 
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Brand Name
CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS
Type of Device
PRIMARY CONSOLE WITH ADULT FLOW PROBE
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ  CH-8005
MDR Report Key8192714
MDR Text Key131797725
Report Number2916596-2018-05624
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 10/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number201-90401
Device Catalogue Number201-90401
Device Lot Number5584897
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/07/2018
Initial Date FDA Received12/21/2018
Supplement Dates Manufacturer Received05/29/2019
10/08/2019
Supplement Dates FDA Received05/30/2019
10/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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