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

Model Number 201-90411

Device Problems Electrical /Electronic Property Problem (1198); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2022

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

It was reported that the centrimag had fluctuating rotations per minute (rpm) while in use and the console and motor were exchanged.The console was also noted to have an active b4 battery error.Battery maintenance was performed and the issue resolved.Related manufacturer's reference number for the motor: 3003306248-2022-00029.

Manufacturer Narrative

Section d4 expiration date: a date was incorrectly provided in the previous report.Expiration date is not applicable for centrimag 2nd generation primary console.Manufacturer's investigation conclusion: the reported events of a b4: battery maintenance alarm and the system¿s speed fluctuating while the console was in use were not confirmed.The centrimag console (serial number (b)(6)) was not returned for analysis, and no log files were associated with the reported event.Per additional information, the reported battery alarm resolved upon performing battery maintenance.The root causes of the reported events were unable to be conclusively determined through this analysis.Review of the device history record for the centrimag console, serial number l04900-0001, showed the battery was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual (rev.M) has an emergency/troubleshooting section for the 2nd generation console in section 10.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.M) section 9.4 entitled ¿battery maintenance¿ instructs users on how to perform the battery maintenance procedure.The 2nd generation centrimag system operating manual (rev.M) section 12.1 entitled "appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including battery alarms, 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 battery maintenance was performed and the console issue resolved.The motor was sent for evaluation due to intermittent interruptions in flow and fluctuating revolutions per minute (rpms).

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• 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 Key: 13579909
• MDR Text Key: 286772610
• Report Number: 3003306248-2022-00028
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

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 Expiration Date: 10/31/2018
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 5750335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 03/30/2022
• Supplement Dates FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 138 KG