MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

Model Number 201-30300

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2018

Event Type  Injury  

Manufacturer Narrative

This event occurred at the (b)(6). Approximate age of device - 4 years. The centrimag console is not a single use device. Investigation conclusion: the reported event of a s3 alarm was confirmed. The centrimag 2nd generation primary console was returned to mcs zurich for analysis. The log file was downloaded from the console for review. A review of the downloaded log file showed the console operating as intended and displaying flow correctly until (b)(6) 2018. The sub fault ¿sf_ifd_flow_data¿ activated and triggered the ¿system alert: s3¿ in april, may, and november 2018 as well as january 2019. The returned console was connected to mains power supply and the returned and associated flow probe, test motor, test loop, and test pump were connected to the console. The unit was switched on and following the startup sequence alerted for ¿system alert: s3¿. The s3 alert could only be muted, but not cleared. The pump speed was increased to 1000 rpm; however, no flow was recorded when the speed was set. The system was able to operate at different pump speeds (500 rpm ¿ 5500 rpm). A test flow probe was connected to the console; however, still no flow was recorded. The console did not alarm when the flow probe was disconnected and was not able to recognize when the flow probe was reconnected. The console always showed blank flow. The ¿system alert: s3¿ alarm was still present when the console was powered on, and both the test and returned flow probe were not recognized by the console. The console¿s flow board was suspected for the problem with measuring and displaying the flow values. The console¿s original flow board was replaced with a new one and the console was switched on and was able to recognize both the test flow probe and the associated flow probe. The console registered flow as intended. The original flow board was determined to be defective. No further troubleshooting was able to be performed on the flow board due to the flow board being supplied by the external company, emtec/germany. No schematics are available. The repaired console was subjected to the repair and maintenance procedure with the associated flow probe and passed all tests. The s3 alert did not reoccur. The root cause for the reported s3 alarm was conclusively determined to be due to a defective flow board. No further information was provided. The manufacturer is closing the file on this event.

Event Description

It was reported that a centrimag console gave s3 alarms. There was no patient involvement with this event. No further information was provided.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE
• 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 Key: 8842042
• MDR Text Key: 152673285
• Report Number: 2916596-2019-03682
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: SA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown