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

Model Number	104172
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that the customer purchased a set of batteries for their centrimag system and one was not holding charge.An exchange was requested.
Additional Manufacturer Narrative
B5 updated with information from 25nov2024, investigation activities completed 27nov2024 h8 - usage of device: corrected.Manufacturer¿s investigation conclusion: the reported event of decreased run time on the centrimag console¿s internal battery was not confirmed.Additional information provided indicated that the battery would be returned for analysis; however, no products have been returned to date.This file will be reopened with further analysis if any products are returned at a later date.The root cause of the reported event could not be conclusively determined through this analysis.Per the device history records (dhr) section of (b)(4), a dhr review is not required as no products were returned for analysis.The 2nd generation centrimag system operating manual (rev.M) 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 (rev.M) 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 (rev.M) 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.
Event or Problem Description
There was no patient involvement in this event, as it was discovered during preventative maintenance.
Additional Manufacturer Narrative
Manufacturer¿s investigation conclusion: the reported event of the centrimag¿s internal battery being unable to hold charge was confirmed via analysis of the returned battery.The returned centrimag internal battery (serial number: (b)(6) was installed in a known working test centrimag console and upon powering on the system, a b1: battery module alarm was observed.The console was then connected to a mock circulatory loop and the unit was disconnected from ac power, and the internal battery was unable to support the system.The protective sleeve was then removed from the battery to inspect the underlying components and no issues were observed.The battery¿s cells were measured, revealing that the battery pack had a voltage measurement of approximately 14.6 v, indicating that the battery was in a discharged state.The cell voltages were observed to be balanced.The returned battery was then installed in the test console for several days in an attempt to charge the battery; however, the battery would not charge.No further testing was performed as the battery¿s printed circuit board is potted and cannot be accessed for testing.The root cause of the reported event could not be conclusively determined through this analysis.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 quality assurance specifications.The battery was shipped to the customer on (b)(6) 2024.The 2nd generation centrimag system operating manual (rev.M) 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 (rev.M) 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 (rev.M) 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
• Common Device Name: 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: 20386483
• Report Number: 3003306248-2024-04443
• Device Sequence Number: 12748868
• Product Code: DWA
• UDI-Device Identifier: 07640135140542
• UDI-Public: (01)07640135140542
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K093832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2025

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
• Operator of Device: Health Professional
• Device Model Number: 104172
• Device Catalogue Number: 104172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 11/25/2024; 03/31/2025
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 12/02/2024; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown