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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 Problems Communication or Transmission Problem (2896); Infusion or Flow Problem (2964)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2020
Event Type  malfunction  
Manufacturer Narrative
No additional information was provided. A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
It was reported that the site was having pressure issues with the console. When pressure cables were attached to console the site was unable to activate pressure monitoring. Perfusion stated they changed the console and are now able to get pressure monitoring capabilities using the same pressure cables and monitor.
 
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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 Key10367201
MDR Text Key201845636
Report Number2916596-2020-03666
Device Sequence Number1
Product Code DWA
UDI-Device Identifier07640135140702
UDI-Public07640135140702
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-90411
Device Catalogue Number201-90411
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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