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 10/01/2021

Event Type  malfunction  

Event Description

It was reported that the console failed battery maintenance.The battery was reseated and re-tried twice which did not resolve the issue.The console was replaced for repair.

Manufacturer Narrative

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

Manufacturer Narrative

Section d4: expiration date inadvertently reported in initial report and is not applicable for this device.Manufacturer's investigation conclusion: the reported event of the console not passing battery maintenance was confirmed.The centrimag 2nd generation primary console (serial#: (b)(6) was returned for analysis and a log file was downloaded for review with events spanning approximately 7 days (on (b)(6) 2021 per time stamp).Events occurring on (b)(6) 2021 took place during lab testing.Battery maintenance was being performed throughout the entire log file and it was noted to have not passed twice, on (b)(6) 2021 at 10:29 and on (b)(6) 2021 at 11:40.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was returned for analysis to the service depot and the reported event was able to be duplicated and verified.Battery maintenance was attempted twice and was unsuccessful each time.Battery maintenance was attempted again with a new battery and was completed successfully.It was determined that the old battery which was set to expire on 31dec2021.The battery was not holding charge.After the battery replacement, the console operated as intended.A full functional checkout was performed, and the unit passed all tests.The replaced battery was forwarded to product performance engineering (ppe) for further analysis.Upon further analysis with ppe, the battery underwent battery maintenance and did not pass.The battery was connected to a test equipment and the console alerted for "battery maintenance required: b4".The motor speed was set to 5500 rpm and ac power was disconnected.The battery was able to support the system with no issue.The battery was further investigated and there were no physical anomalies found.The battery printed circuit board (pcb) is potted and unable to be accessed.No further troubleshooting was able to be performed.The root cause for the reported event was unable to be conclusively determined through this analysis.Incidental findings: damaged housing.The device history records were reviewed for the centrimag 2nd generation primary console (serial#: (b)(6) and the console was found to pass all manufacturing and qa specifications.The battery (serial#: (b)(6) was shipped with the console.The 2nd generation centrimag system operating manual section 4 entitled "warnings & precautions" warns "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 pedivas blood 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 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary 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 backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual table 13 entitled ¿console alarms & alerts¿ details the various alarms and alerts and the appropriate operator response, including b4 alarms.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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 12720874
• MDR Text Key: 281426246
• Report Number: 3003306248-2021-05698
• 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: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2021
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 7312111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2019
• 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