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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 102954
Device Problems Noise, Audible (3273); Excessive Heating (4030)
Patient Problem Thrombus (2101)
Event Date 08/02/2019
Event Type  Injury  
Manufacturer Narrative
The centrimag motor was captured under mfr# 2916596-2019-03827. The centrimag blood pump was captured under mfr# 2916596-2019-03835. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
The patient was implanted with an extracorporeal circulatory support pump on (b)(6) 2019. It was reported that the patient was in cardiogenic shock and was initiated on dual centrimag acute support with an oxygenator attached to the right-sided support. Going into the intensive care unit (icu), the left ventricular assist device (lvad) was set at 4000 with 4. 7lpm flow and the right vad was set at 2700 with 4lpm flow. Approximately an hour after getting into the icu from the operating room, the cardiologist received an s3 alarm with a loud noise coming from the motor and pump on the lvad and that the motor was hot to the touch. Healthcare professionals immediately switched to the backup motor and there have been no alarms since. The patient was in critical health status due to being in shock and not due to the event. It was also reported that there was additional incident on (b)(6) 2019 in the evening following the switch to full backup system due to rattling sound from pump and s3 alarm. No further alarms have occurred since the switch to full backup system. Photos were provided of the pump secured in the motor on the new system to ensure secure pump placement. On (b)(6) 2019, the patient experienced significant flow fluctuations and apparent suck down at drainage cannula. Volume was given to the patient but flow fluctuations persisted. The patient was taken to the catheterization lab where a "huge left ventricle thrombus" was identified. This was thought to be the cause of the drop in flow and flow fluctuations and the patient was otherwise doing fine. Treatment for the thrombus was to explant the centrimag and implant with a heartmate 3 lvad on (b)(6) 2019. The centrimag console was added as a result of the investigation that concluded other causes may have contributed to the reported events besides thrombus.
 
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Brand NameCENTRIMAG 1ST 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 Key9576361
MDR Text Key176011415
Report Number2916596-2020-00153
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number102954
Device Catalogue Number102954
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/10/2020 Patient Sequence Number: 1
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