• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

THORATEC SWITZERLAND GMBH PRIM CONS 1ST GEN, STANDALONE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-90150
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/05/2020
Event Type  malfunction  
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 during use of the centrimag system for circulatory support the primary console did not show flow measurement. The clinical team changed the flow probe from the backup unit and there was still no blood flow displayed on the primary console. The clinical team then changed the centrimag primary console to the centrimag backup console. After the console was exchanged the flow measurement was immediately displayed. The clinical team checked both flow probes on the working backup console with proper function. Because of this, the suspected malfunction origin was the centrimag primary console. The unit was taken out of use. The patient did not experience any adverse consequences.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9909997
MDR Text Key189325901
Report Number3003306248-2020-00017
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeBU
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
Report Date 06/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-90150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-