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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 Mechanical Problem (1384); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2020
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
Related manufacturer reference number: 3003306248-2020-05466. It was reported that about half an hour of regular operation on the centrimag, a loud noise was heard coming from the motor/pump without any alarms. Troubleshooting was performed by stopping the machine in order to reposition the pump but there was no resolution. The process was repeated without success. After the second attempt to reposition the pump, an "engine disconnected" alarm appeared on the console. The motor was exchanged, but the alarm persisted. The console was turned off and then on again to try to reset the system, but no resolution. The console was exchanged. The therapy was restarted. There was no consequences to the patient. No further information was provided.
 
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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 Key10852793
MDR Text Key244565363
Report Number3003306248-2020-05467
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K131179
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 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
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? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/08/2021
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 Reuse

Patient Treatment Data
Date Received: 11/17/2020 Patient Sequence Number: 1
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