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

Model Number 201-90411

Device Problems Insufficient Information (3190); Excessive Heating (4030)

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

Event Date 11/30/2020

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 #: 3003306248-2020-06202.It was reported that the motor failed while on the patient.The balloon tech stated that the motor drive was very hot when they swapped it with the backup centrimag and motor drive.The devices were returned for evaluation.

Manufacturer Narrative

Section a: patient information was requested but not provided.Manufacturer's investigation conclusion: the reported event of the motor overheating 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 with events spanning approximately 3 days (30nov2020 ¿ 01dec2020, 04dec2020 per time stamp).The events occurring on 04dec2020 took place during lab testing at abbott.The console was operating a motor at ~3900 rpm with a flow of ~5.2 lpm.On 30nov2020 at 18:08:08 a shutdown occurred as indicated by the sub-fault ¿sf_ifd_shutdown_detected¿.Quickly following the shutdown, at 18:08:10, the log file captured the motor speed decreasing to 3463 rpm before it was no longer detected and a ¿motor disconnected: m2¿ alarm activated.A ¿motor alarm: m4¿ alarm activated at 18:08:35, and the flow decreased.Following this event at 18:11:23, a ¿motor over temp: m6¿ activated.A second ¿motor disconnected: m2¿ alarm activated at 18:11:48 and the earlier m4 alarm cleared.Attempts to increase the motor speed to 900 rpm and 1000 rpm were respectively made at 18:11:48 and 18:12:10 without success.The pump was removed at 18:13:50 and the console was powered off at 18:14:53.There were no other notable alarms active in the log file.The console and the returned and associated motor and flow probe were run and inspected for 24 hours on a test loop.During this period, there were no alarms or excessive heat observed.The motor cable was thoroughly flexed along its entire length and continued to operate as intended.The reported event was unable to be reproduced.The console lmcebpx printed circuit board (pcb) was replaced as a precaution and the console was retested.The console functioned as intended and passed all tested.The console was returned to the customer.The root cause for the reported event was unable to be conclusively determined through this analysis.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.The device history records were reviewed for the centrimag second generation console (serial #: (b)(6) and was found to pass all manufacturing and qa specifications.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: 11058787
• MDR Text Key: 223460189
• Report Number: 3003306248-2020-06201
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR