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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 Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Date 10/15/2019
Event Type  Injury  
Manufacturer Narrative
The cause of the event is unknown. This event is also reported on cmag motor under mfr #2916596-2019-05050. 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 centrimag (cmag) console 1st generation does not show the flow parameter during maintenance check. The issue continued even when the console was connected to a different motor. The console was replaced. There was no issue with the cmag motor which was used with a different console for troubleshooting purpose.
 
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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 Key9304316
MDR Text Key166369582
Report Number2916596-2019-05020
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K093832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-30100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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