MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102956

Device Problems Temperature Problem (3022); 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 # 3003306248-2020-06201.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

Manufacturer's investigation conclusion: the reported event of the motor overheating was confirmed via the log file.The centrimag motor (serial #: l04507-0006) was returned for analysis and a log file was downloaded from the returned console.A review of the downloaded log file showed events spanning approximately 3 days ((b)(6) 2020per 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 (b)(6) 2020 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 centrimag motor was functionally tested with the returned and associated centrimag 2nd generation primary console 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 motor was visually inspected, and a kink was observed near the bend relief.The motor was subsequently scrapped.The root cause for the reported event was unable to be conclusively determined through this analysis; however, the kink in the motor cable has the potential to cause internal conductor breakdown.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 motor (serial #: (b)(6)) and the motor 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 MOTOR, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 11058796
• MDR Text Key: 223457882
• Report Number: 3003306248-2020-06202
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Notification
• 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: 102956
• Device Catalogue Number: 102956
• 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
• Removal/Correction Number: FA-Q318-MCS-1
• Patient Sequence Number: 1
• Treatment: CENTRIMAG CONSOLE