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

Model Number 201-90411

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Infusion or Flow Problem (2964)

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

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Related manufacturer¿s report # 2916596-2020-03880.It was reported that the patient experienced m2, f2 and b6 alarms during startup, with the motor plugged in.The site communicated that the console was plugged into the wall and powered on when the alarms visualized m2 motor disconnected, f2 flow signal interrupted.The motor was unplugged from the console, the prongs and cable inspected but no visual imperfections were noted.The site plugged the motor back in, and the m2 alarm was still present.The site inserted the training loop into the motor head, attached flow probe which resolved the f2 alarm.The site then removed motor from console, plugged in demo motor (not for patient use) visualized resolution of m2 alarm, increased rpms and confirmed properly functioning.

Manufacturer Narrative

Section d3: correction.

Manufacturer Narrative

Section d4: expiration date is not applicable for this device.Manufacturer's investigation conclusion: the reported event of m2 alarms were not confirmed; however, the reported f2 and b6 alarms were confirmed.The centrimag 2nd generation primary console (serial #: (b)(6) was returned for analysis and a log file was submitted for review.A review of the downloaded log fie showed events spanning approximately 7 days (b)(6) 2020, (b)(6) 2021 per time stamp).The reported event date was not captured within the log file.Events occurring on (b)(6) 2021 took place during lab testing at abbott.Several ¿flow signal interrupted: f2¿ were active throughout the log file.On (b)(6) 2020 at 16:21 a f2 alarm activates prior to a pump stop due to user request at 16:26.On (b)(6) 2021 following startup of the console at 17:32, a f2 alarm activated and cleared.At 17:35, a ¿flow signal interrupted: f2¿ activated again.All f2 alarms were able to be muted and cleared.Routine ¿on battery: b6¿ alarms were active throughout the log file when the console was operating on battery power.There were no other notable alarms active in the log file.The console evaluated and tested and the reported m2, f2, and b6 alarms observed at startup were not able to be confirmed during testing.The console was tested on a test loop for 72 hours with no alarms present.The console functioned as intended.The root cause for the reported alarms 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 2nd generation primary console (serial #: (b)(6), and the console 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 CA CH-80 05; SZ CH-8005
• MDR Report Key: 10390747
• MDR Text Key: 202453443
• Report Number: 2916596-2020-03881
• 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,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6804156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 08/17/2020; 03/16/2021
• Supplement Dates FDA Received: 08/21/2020; 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR, US; CENTRIMAG MOTOR, US