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

Model Number L201-90401

Device Problem Insufficient Information (3190)

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

Event Date 12/12/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a motor disconnected message appeared when going to purge the pump and the engine could not start up.The connection was checked, and the engine still did not start.The console and motor were changed and the procedure was continued with no problem.The console and motor would be returned for evaluation.Related manufacturer reference report: 3003306248-2022-14529.

Event Description

Additional information: the patient was in good condition.

Manufacturer Narrative

Manufacturer's investigation conclusion: incidental findings: use of expired battery.The reported event of a motor disconnected alarm was confirmed via the submitted log file.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 6 days ((b)(6), 2022 ¿ (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2023 per time stamp).The pump was operating at a speed of ~3400 rpm with a flow of ~3.5 lpm.On 11dec2022 at 07:46, a ¿motor disconnected: m2¿ and ¿flow below minimum: f3¿ alarms activated.The pump speed dropped to 0 rpm and the flow dropped to ~0 lpm.The m2 alarm cleared and reactivated again at 07:47.The motor speed was increased to 2700 rpm at 07:49 and the m2 and f3 alarms cleared.The motor speed was successfully adjusted several times with no issues in motor operation until the system was shutdown at 09:18.The system was power cycled several more times.There were no other notable events active in the log file.The centrimag 2nd generation primary console was returned for analysis to the european distribution center (edc) and was evaluated and tested.The console underwent functional testing and operated as intended.The reported event was unable to be reproduced during testing.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed for centrimag 2nd generation primary console and the console was found to pass all manufacturing and qa specifications.The 2nd generation centrimag system operating manual (rev.M) 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 (rev.M) 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 (rev.M) table 16 entitled ¿console alarms & alerts¿ addresses how to interpret and troubleshoot all system alarms including m2 and f3 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: 16007636
• MDR Text Key: 308233335
• Report Number: 3003306248-2022-14530
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 7640135140702
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L201-90401
• Device Lot Number: 5533051
• 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: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• 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