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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 201-90401
Device Problem Insufficient Information (3190)
Patient Problem Low Oxygen Saturation (2477)
Event Date 08/17/2021
Event Type  malfunction  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted once the manufacturer¿s investigation is completed.
 
Event Description
Related manufacturer's report #s: 3003306248-2021-04033, 3003306248-2021-04032 it was reported that the patient was on centrimag support, when an s3 alarm displayed. The patient's physicians proceeded to change the flow probe. After the flow probe was exchanged, the flow value was no longer visible and the alarm persisted. The patient's spo2 levels dropped. The console and the motor were exchanged, and the system then continued working without any further alarms.
 
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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 Key12490559
MDR Text Key271988805
Report Number3003306248-2021-04031
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K020271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-90401
Device Lot NumberL06945
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/17/2021 Patient Sequence Number: 1
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