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

Model Number 201-90411

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that a hospital called with a centrimag that had b1 and b2 alarms.The battery was unable to operate the system.It was noted that the last battery maintenance was completed and passed in sep2020.The unit was added to the hospital inventory in jan2020.The site was instructed to run a battery maintenance procedure on the unit.If the issue still occurred, then to replace the battery no additional information was provided.

Event Description

Related manufacturer report number: 3003306248-2021-01081.

Manufacturer Narrative

Manufacturer's investigation conclusion: the centrimag console (serial number: (b)(6) was evaluated due to the reported event of b1, b2, and b3 battery alarms.However, the console was not returned for analysis and no log files were associated with the reported event.The console¿s battery (serial number: (b)(6), investigated separately under related mfr: 3003306248-2021-01081) was returned for analysis and was found to have been related to the root cause of the reported event.No further issues regarding the console were reported.Review of the device history record for the centrimag console, serial number: (b)(6), showed the console was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual 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 section 9.4 entitled ¿battery maintenance¿ instructs users on how to perform the battery maintenance procedure.The 2nd generation centrimag system operating manual section 12.1 entitled "appendix i ¿ primary 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.

• 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
• MDR Report Key: 11454122
• MDR Text Key: 239462227
• Report Number: 3003306248-2021-01070
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

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: 08/31/2021
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 7139324
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THORATEC RECHARGEABLE LI-ION BATTERY.