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

Model Number 201-30300

Device Problem Insufficient Information (3190)

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

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During the investigation of this centrimag console, it was found that on (b)(6) 2021 at 16:27:37 the motor was stopped due to a user request.The pump speed fell to 0 rpm.At 16:28:03 a can bus send error was activated, triggering a system alert s3 activated.The alarm was muted, the console was powered down, restarted and did not reoccur.

Event Description

Related manufacturer report number: 3003306248-2021-04009.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a s3 alarm was confirmed via the log file.The centrimag 2nd generation primary console (serial #: (b)(6) ) was not returned for analysis.A review of the log file showed events spanning approximately 24 days ((b)(6) 2019, (b)(6) 2020, (b)(6) 2021 per time stamp).On (b)(6) 2020 at 16:27:37, the motor was stopped due to user request.The pump speed fell to 0 rpm with a flow of 0 lpm.At 16:28:03, a can bus send error activated, triggering a ¿system alert: s3¿ alarm activated.The alarm was able to be muted.The console was powered down and the alert did not recur.Additional provided information communicated on 05aug2021 stated that there was a patient on the device at the time of the event.There were no adverse effects for the patient.The root cause of the reported event was unable to be conclusively determined through this analysis.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 quality assurance specifications.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 section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events, including s3, b2, b4, and b5 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
• MDR Report Key: 12333556
• MDR Text Key: 267088555
• Report Number: 3003306248-2021-04008
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1