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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG PRIMARY CONSOLE 2ND GENERATION CENTRIMAG PRIMARY CONSOLE

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THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG PRIMARY CONSOLE 2ND GENERATION CENTRIMAG PRIMARY CONSOLE Back to Search Results
Catalog Number 201-30300
Device Problem Failure to Pump (1502)
Patient Problems Bradycardia (1751); Death (1802); Hypoxia (1918)
Event Date 01/17/2016
Event Type  Death  
Manufacturer Narrative
Age/date of birth at time of event; weight were not provided. Information received referred to the patient as a "kid". Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation. The primary console is not a single use device. Approximate age of the device is 3 years and 8 months (calculated from the ship date of the primary console). The device has been returned for investigation. The evaluation is not yet complete. The event occurred at hospital (b)(6). No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is complete.
 
Event Description
It was reported that the pediatric patient was placed on an extracorporeal circulatory support device to implement extracorporeal membrane oxygenation (ecmo) for severe acute respiratory distress syndrome. It was reported that the patient was immunocompromised prior to the procedure. The patient was cannulated via unspecified vessels in the neck without issue. After connecting the ecmo circuit it was reported that a blood flow of -250 milliliters per minute of desaturated arterial blood was detected, and that the pump was not rotating. The negative blood flow reading did not increase despite attempts to increase the revolutions per minute of the pump. The resistance in the circuit became higher than the patient¿s blood pressure causing a reduction in flow. Due to lack of flow and low pressure in the venous line the blood became bright red from the diffusion of gases and oxygen from the oxygenator. The cannulae were repositioned under ultrasound and the ecmo circuit was replaced without any improvement. The patient desaturated and became bradycardic requiring multiple doses of adrenaline. The thorax was opened emergently and central cannulation of the ecmo circuit was performed. Another attempt was made to initiate ecmo support, and it was reported that the same scenario as described above occurred. The console in use was then power cycled and began to function as expected. It was reported that the event had relevant clinical consequences since the patient needed to be ¿reanimated¿ due to the delay in the initiation of ecmo support. The patient expired four days after the event due to sepsis that ultimately prevented the use of ecmo support.
 
Manufacturer Narrative
The returned console and motor operated as intended throughout their analysis. The reported event could not be confirmed and no fault was found with the returned devices. A review of the device history records revealed no deviations from manufacturing or quality assurance specifications. The manufacturer is closing the file on this event.
 
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Brand NameTHORATEC CENTRIMAG PRIMARY CONSOLE
Type of Device2ND GENERATION CENTRIMAG PRIMARY CONSOLE
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
ch-8005 zurich
SZ
Manufacturer (Section G)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zürich CA CH-80 05
SZ CH-8005
Manufacturer Contact
robert fryc
23 fourth avenue
burlington, MA 01803
781272-013
MDR Report Key5499609
MDR Text Key40299006
Report Number2916596-2016-00462
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number201-30300
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/14/2016 Patient Sequence Number: 1
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