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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH PRIM CONS 1ST GEN, STANDALONE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH PRIM CONS 1ST GEN, STANDALONE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-30100
Device Problems Alarm Not Visible (1022); Display or Visual Feedback Problem (1184)
Patient Problem Cardiopulmonary Arrest (1765)
Event Date 05/06/2020
Event Type  Injury  
Manufacturer Narrative
This event occurred at (b)(6). No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is complete.
 
Event Description
Related manufacturer report number: 3003306248-2020-00040. It was reported that the patient had recently been converted from venoarterial extracorporeal membrane oxygenation (va-ecmo) to centrimag left ventricular assist device (lvad) support. On (b)(6) 2020 the centrimag system stopped, there was a loss of rotational speed at the motor. Circulatory support was interrupted and the patient hemodynamically deteriorated which necessitated cpr to restore acceptable circulation. The physicians were unable to restore power to the centrimag motor due to a missing set rpm option on the screen of the primary console. The whole centrimag system was exchanged for a backup one. It was also noted that the centrimag motor was extremely hot during the event. After exchange to the backup centrimag system, circulatory support was re-established and the patient hemodynamically stabilized. The physicians reportedly did not remember any active alarms during the event.
 
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Brand NamePRIM CONS 1ST GEN, STANDALONE
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 Key10101597
MDR Text Key194132487
Report Number3003306248-2020-00039
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeLO
PMA/PMN Number
K093832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number201-30100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/31/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/29/2020 Patient Sequence Number: 1
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