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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-90411
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/29/2019
Event Type  Injury  
Manufacturer Narrative
This event was also reported against the centrimag motor in mfr. Report #2916596-2020-00490. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported that the patient was on venous-venous extracorporeal membrane oxygenation (ecmo) while awaiting a lung transplant. The patient had been on centrimag for about 5 days prior to the event occurring. On the evening of (b)(6) 2019, the patient was being prepared to go to the operating room for the lung transplant when the flow on the centrimag console showed '- - - -'. No alerts or alarms were displayed. A new console and flow probe was added to see if a flow would be displayed, but kept the original motor in place connected to the original console. The addition of the second console and flow probe was just to read flow. The flow remained steady and the backup console and flow probe read the flow while the original console still read the rpms. During this troubleshooting the original console displayed dashes while the new console and flow probe displayed a flow. During the lung transplant, the motor was switched over to the backup console and removed the original console and flow probe. So now the patient had the backup console, flow probe and the same original motor. After the case, the original console and flow probe was used on the patient¿s line and it read flow again, so it seemed like it was working fine. No further information was provided.
 
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Brand NameCENTRIMAG 2ND GENERATION PRIMARY CONSOLE
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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 Key9648057
MDR Text Key179423899
Report Number2916596-2020-00492
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-90411
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/30/2020 Patient Sequence Number: 1
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