MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH ADULT FLOW PROBE, CAN; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90421

Device Problems Communication or Transmission Problem (2896); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that during testing of the primary console a power on test fail alarm occurred.The account rebooted the system but the alarm kept occurring.The account left the system alone for awhile, when they booted up the system a second time a motor disconnected alarm occurred.The account switched to the backup system, however, the alarm still occurred.No further information was provided.

Manufacturer Narrative

Section g1, g2: correction.Section h3: additional information.Section h4: additional information.Manufacturer investigation conclusion: the reported event of a power on test failed alarm confirmed via the downloaded log file.The centrimag 2nd generation primary console (serial #: b)(6)) was returned for analysis and a log file was downloaded from the returned console for review.A review of the downloaded log file showed events spanning approximately 318 days (b)(6) 2019 ¿ (b)(6) 2019 per time stamp).On (b)(6) 2019, several ¿power on self test fail: s1¿ alarms occurred when the console was powered on.These alarms occurred at the time stamps of 09:45, 09:53, 13:30, and 13:37.The alarm caused the sub faults ¿sf_sps_power_button_stuck¿ and ¿sf_sps_power_button_inconsistent¿ to activate and trigger a ¿system fault: s3¿ alarm.The alarms cleared when the console was powered off.The console was evaluated and tested.The reported event was unable to be duplicated or verified.The console underwent a successful software update.The console was powered on and successfully passed the startup self-test.The console was run with the returned and associated motor (serial #: (b)(6)) and flow probe (serial #: (b)(6)).The console functioned as intended and no alarms were active at any point.A full functional checkout was performed, and the unit passed all tests.The console was returned to the customer.The root cause for the reported event was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH ADULT FLOW PROBE, CAN
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 9469197
• MDR Text Key: 170860486
• Report Number: 2916596-2019-05747
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

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 Number: 201-90421
• Device Catalogue Number: 201-90421
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention