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

Model Number 201-90411

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2019

Event Type  Injury  

Manufacturer Narrative

This event was also reported against the centrimag motor in mfr.Report #2916596-2020-00490.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient was on venous-venous extracorporeal membrane oxygenation (ecmo) while awaiting a lung transplant.The patient had been on centrimag for about 5 days prior to the event occurring.On the evening of (b)(6) 2019, the patient was being prepared to go to the operating room for the lung transplant when the flow on the centrimag console showed '- - - -'.No alerts or alarms were displayed.A new console and flow probe was added to see if a flow would be displayed, but kept the original motor in place connected to the original console.The addition of the second console and flow probe was just to read flow.The flow remained steady and the backup console and flow probe read the flow while the original console still read the rpms.During this troubleshooting the original console displayed dashes while the new console and flow probe displayed a flow.During the lung transplant, the motor was switched over to the backup console and removed the original console and flow probe.So now the patient had the backup console, flow probe and the same original motor.After the case, the original console and flow probe was used on the patient¿s line and it read flow again, so it seemed like it was working fine.No further information was provided.

Manufacturer Narrative

Additional information on section h3, h4 manufacturer's investigation conclusion: the reported event of the console showing blank flow was confirmed via the log file.The centrimag 2nd generation primary console was returned for analysis and was evaluated and tested under work order # (b)(4).The reported event was unable to be verified or duplicated.The console was tested with the returned and associated motor, and a test flow probe.Checked at every specified pump rpm and flow speeds, no issues were found, and no dashes were displayed at any point.A full functional checkout was performed, and the unit passed all tests.The console will be returned to the customer site.A log file was downloaded from the returned console.A review of the downloaded log file showed events spanning approximately 22 days (29dec2019 ¿ 20jan2020 per time stamp).The motor was running a pump at a speed of ~4300 rpm with a flow of ~3.81 lpm.On (b)(6) 2019 at 21:04, a tech: flow error triggered the sub fault ¿can bus send error¿ and ultimately activated a ¿system alert: s3¿ alarm.The flow dropped to 0 lpm.At the time stamp 21:07, a ¿flow signal interrupted: f2¿ alarm activated.There were no other notable alarms active in the log file.The root cause for the reported event was not conclusively determined through this analysis.There were incidental findings of cosmetic damage to the housing 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 has an emergency/troubleshooting section for the 2nd generation console.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 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.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: 9648057
• MDR Text Key: 179423899
• Report Number: 2916596-2020-00492
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention