MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG PRIMARY CONSOLE INTERNAL BATTERY; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-50207

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 12/31/2023

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported that a b1 alarm on the centrimag ii console occurred.The console battery was replaced with new battery, but the alarm returned.Related manufacturer reference number: 3003306248-2024-00008.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the centrimag internal battery (serial number: (b)(6)) was returned for evaluation following the reported event of a b1 alarm; however, it was determined that the returned battery was unrelated to the root cause of the event.The returned centrimag battery was functionally tested, and the battery operated as intended throughout testing.A log file was downloaded from the returned centrimag console (serial number: (b)(6)).The data in the log file did not indicate any issues with the returned centrimag battery.It was revealed that the root cause of the reported event was related to the returned centrimag console (serial number: (b)(6)).The console¿s evaluation along with further analysis of the log files associated with this event have been addressed via the console investigation.The reported event could not be correlated to an issue with the returned centrimag battery.The device history records were reviewed and the records revealed that the centrimag battery, serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The battery was shipped to the customer on 26apr2023.The 2nd generation centrimag system operating manual section 10 ¿ ¿emergencies/troubleshooting¿ provides instructions for operation when there is a need to exchange the main console or motor with a backup console or motor.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 4 ¿ "warnings & precautions" states that 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 pedimag 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 section 12.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), including battery alarms, and the appropriate actions to take if the issue does not resolve.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG PRIMARY CONSOLE INTERNAL BATTERY
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18459703
• MDR Text Key: 332725885
• Report Number: 3003306248-2024-00009
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140535
• UDI-Public: 07640135140535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093832
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-50207
• Device Lot Number: 8937572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2023
• 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