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 12/31/2023

Event Type  malfunction  

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: 3003306248-2024-00009.

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 prior to initiating mechanical circulatory support on any patient.A different console was used, and the unit was immediately taken out of service & clinical engineering got involved.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the reported event of a b1 alarm was confirmed via analysis of the returned centrimag console.The returned centrimag console (serial number: (b)(6)) was evaluated by service depot alongside known working test centrimag equipment.During testing, a b1 alarm was observed during the console¿s boot up sequence, reproducing the reported event.The console was then disassembled to inspect the internal components and it was determined that the resistor pre-assembly was compromised.The compromised resistor pre-assembly was replaced with a new part and the issue resolved.A full functional checkout was then performed and the console passed all steps of the test without any issues.The serviced and repaired console was returned to the customer site after passing all tests per procedure.The compromised resistor pre-assembly was forwarded to product performance engineering (ppe) for further analysis.Ppe evaluation of the returned resistor pre-assembly revealed that one of the load resistors was electrically open.Damage to this component would cause the console¿s internal battery to not pass testing during the console¿s bootup sequence, which would result in the reported b1 alarms.The downloaded log file contained approximately 4 days of data combined (18dec2023 ¿ 21dec2023, 28dec2023 from 12:10 ¿ 12:34, 30dec2023 ¿ 31dec2023, and 02jan2024 from 11:25 ¿ 13:18 per the timestamp).The log file captured intermittent b1 alarms from 30dec2023 at 23:19 to 01jan2024 at 13:17 that correlated to an issue with the battery maintenance circuitry.The alarms occurred each time when console was performing its bootup sequence.These alarms are consistent with the resistor pre-assembly being compromised.The reported event was determined to be due to a compromised component; however, the root cause of the damage could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed that the centrimag console, serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The centrimag console was shipped to the customer on 07oct2020.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 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18459680
• MDR Text Key: 332731077
• Report Number: 3003306248-2024-00008
• 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: 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 Expiration Date: 07/31/2022
• Device Model Number: 201-90411
• Device Lot Number: 7569858
• 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: 07/19/2020
• 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