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

Model Number 201-90411

Device Problem Complete Loss of Power (4015)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Related manufacturer's report number: 2916596-2020-06301 for centrimag 2nd generation primary console l02121-0002.Related manufacturer's report number: 2916596-2020-06302 for centrimag motor, us l06413-0007.Related manufacturer's report number: 2916596-2020-06303 for centrimag motor, us l00085-0019.It was reported that the patient was on bivad centrimag pumps.The centrimag was unplugged from the wall with full battery status and the pump shut off.Both consoles and motors were exchanged to back-up devices.

Manufacturer Narrative

Section a: patient information was requested but not provided.Manufacturer's investigation conclusion: the reported event of the pump stopping was confirmed via the log file.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis and a log file was downloaded for review.A review of the downloaded log file showed events spanning approximately 2 days ((b)(6) 2020, (b)(6) 2021 per time stamp).Events occurring on (b)(6) 2021 took place during lab testing at abbott.Operating on battery power on (b)(6) 2020 at 06:45:28 a ¿flow below minimum: f3¿ and a ¿motor disconnected: m2¿ alarm activated, and the flow was recorded to be negative and the motor speed dropped to 0 rpm.The m2 alarm cleared at 06:45:32 and was followed by the activating of a ¿pump not inserted: m3¿ activated at 06:46:30.The flow increased from negative values to ~4 lpm at 06:46:50, which cleared the f3 alarm.The motor speed began increasing from 0 rpm to ~4500 rpm at 06:49:00 clearing the m3 alarm.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was functionally tested with both of the returned motors and a test loop and operated as intended.The console was also teste with a test motor and test loop and operated as intended.The reported event was unable to be reproduced during this investigation.The console passed all functional testing before being returned to the customer.Multiple good faith efforts were sent to retrieve additional information including if there were any adverse events and the patient status; however, no response was received.The root cause for 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.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: 11088843
• MDR Text Key: 225605281
• Report Number: 2916596-2020-06300
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• 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: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 7071778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CENTRIMAG MOTOR, US; CENTRIMAG MOTOR, US