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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 Problem Infusion or Flow Problem (2964)
Patient Problems Cardiac Arrest (1762); Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2019
Event Type  Injury  
Manufacturer Narrative
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 nurse noticed reduced flow on the console, which was followed by complete motor failure. There was no blood flow through the device. The patient experienced desaturation/peri-arrest for 20 to 30 seconds while the healthcare team exchanged the console and motor. Blood flow was restarted once the system was exchanged. No further information was provided.
 
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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 Key10020361
MDR Text Key193305896
Report Number3003306248-2020-00019
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K093832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-30100
Device Catalogue Number201-30100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/19/2008
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: 05/04/2020 Patient Sequence Number: 1
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