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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 201-30300
Device Problem Display or Visual Feedback Problem (1184)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2020
Event Type  malfunction  
Manufacturer Narrative
This event occurred at (b)(6). No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
Related manufacturer reference number: 3003306248-2020-00089. It was reported that the patient was connected to centrimag as a ecmo therapy. Suddenly the screen of the console turned off and the flow probe did not register information about the flow, but the motor was still working. No product will be returned, the patient was still under ecmo therapy at time of reported event. Distributor loaned two other motors. The event resolved with the use of the backup motor and console. The backup motor was used, and changed motors as soon as possible. Additional information received on 08oct2020 stated that the motors were affected by the fsca 2019-08, which states that the customers have experienced unexpected console screen blanking, low flow or no flow, and motor behavior including noise, vibration and heating at a rate of (b)(4). Our investigation has identified certain centrimag motors with serial numbers have an increased susceptibility to electromagnetic interference (emi). The issue can be mitigated through re-calibration of the motor. The centrimag¿ 2nd generation console will be returned.
 
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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 Key10715938
MDR Text Key214804777
Report Number3003306248-2020-00088
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K131179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-30300
Device Lot NumberL06473
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2018
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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