• 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 CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO); 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 CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-90401
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2023
Event Type  malfunction  
Manufacturer Narrative
There was no patient involved in this event.The pma# provided is associated with the device¿s most recent approval.Manufacturer's investigation conclusion: the reported event of the centrimag 2nd generation primary console display not functioning was able to be confirmed.The centrimag 2nd gen primary console (serial number: (b)(6) ) was returned for analysis and a log file was downloaded for review.A review of the downloaded log files showed events spanning approximately 4 days (30dec2022, 09jan2023, 11jan2023, 17jan2023, 16mar2023 ¿ 17mar2023 per timestamp).Events captured on 16mar2023 ¿ 17mar2023 took place in the testing labs at abbott.The pump was not connected to the console at any point in the log file.The log file showed only normal startup and shutdown sequences.There were no notable alarms active in the log file.During testing, the display pcb and screen was visually observed and placed in a known working test fixture.The reported event was confirmed when the system turned on and the display screen did not turn on.No further testing was completed at this time.A manufacturing task was previously initiated to investigate the issue of the faulty console display.It was determined that there are controls and instructions in place that the issue would have been detected while performing the final test of the console.The device history record (dhr) review provided evidence that the product was functioning correctly when it was sent out to the customer.It can be concluded that this issue could potentially be related to a manufacturing problem; however, the root cause could not be determined.A supplier corrective action request (scar) was initiated to inform the supplier.A risk task was also initiated to address the issue of the faulty condole display from a risk documentation standpoint.The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed for the centrimag 2nd generation primary console and the console was found to pass all manufacturing and quality assurance (qa) specifications.The 2nd generation centrimag system operating manual (rev.L) section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction.".The 2nd generation centrimag system operating manual (rev.L) section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support.".The 2nd generation centrimag system operating manual (rev.L) has an emergency/troubleshooting section for the 2nd generation console.The recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.The 2nd generation centrimag system operating manual (rev.L) section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.
 
Event Description
It was reported that the centrimag console failed to display any parameters; the screen appeared to be broken.The console was being used for training at the time of the event and there was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)
Type of Device
CONTROL, 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 Key16776314
MDR Text Key313938783
Report Number3003306248-2023-01918
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K020271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number201-90401
Device Lot Number6738947
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/12/2023
Initial Date FDA Received04/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-