MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number L201-90401

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2023

Event Type  malfunction  

Event Description

It was reported that the centrimag console showed an e20 error message.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of flow issues due to a damaged flow socket and an unknown error alarm appearing on the centrimag 2nd generation primary console was unable to be confirmed however flow alerts were confirmed in the log file.The centrimag 2nd generation primary console (serial number: (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 3 days (08feb2023 ¿ 10feb2023, 16may2023 per time stamp).Events occurring on 16may2023 took place during lab testing at abbott.¿flow below minimum: f3¿ following a sf_ifd_flow_below_min sub fault were intermittently active from 09feb2023 at 08:37:36 to 11:02:43.The console was shut down on 09feb2023 at 14:25:25.The console was started again on 10feb2023 at 12:54:02.F3 alarms were intermittently active on 10feb2023 from 13:17:22 to 15:10:59.On 10feb2023 at 15:13:25 ¿flow signal interrupted: f2¿ alarm became active following a sf_flow_low_amplitude sub fault.Shortly after, at 15:14:26 ¿flow sensor disconnected: f1¿ became active.These alarms were active until the pump was stopped by user request on 10feb2023 at 15:30:34.The console was power cycled once more before finally being shutdown to ship the console for evaluation on 10feb2023 at 15:36:39.There were no other notable alarms active in the log file.The centrimag console was returned for analysis in unremarkable condition and was connected to a test monitor, motor, flow probe, and mock loop for functional testing.The console powered on as expected and the system was run for an extended duration without any issues or alarms activating.Additional information provided on 28mar2023 stated that 2 units were sent in however it is unclear what the fault is with the console.It was stated that the flow measuring socket on one console is not functioning as intended, and that several flow measuring probes had a bad contact.A root cause for the reported events was unable to be conclusively determined through this investigation.The device history records were reviewed for the centrimag 2nd generation primary console (serial number: (b)(6) ) and the console was found to pass all manufacturing and qa 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 table 16 entitled ¿console alarms & alerts¿ addresses how to properly interpret and troubleshoot all system alarms including f1, f2, f3, p5, p6, and p7 alarms.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 16672567
• MDR Text Key: 313050283
• Report Number: 3003306248-2023-01915
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L201-90401
• Device Lot Number: 5467990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1