MAUDE Adverse Event Report: THORATEC CORPORATION CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; Control, pump speed, cardiopulmonary bypass

Model Number 201-90411

Device Problems Pumping Stopped (1503); No Flow (2991)

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

Event Date 12/29/2023

Event Type  malfunction  

Event Description

It was reported that a while back, a patient was on support having a brief pump stop where the speed and flow both went to 0 simultaneously for a couple of seconds and then returned to baseline without intervention.Once it occurred twice on the patient, the motor, console, and flow probe were exchanged and sent for evaluation (which came back good).The same thing happened again this past weekend.The patient's speed and flow went to 0 for reportedly 6 seconds and then back to baseline.The nurse reported that the pump running sound disappeared as if it truly stopped during that time.It was noted that the patient had a pump exchange while on support on (b)(6) 2023 with oxygenator removal and that the nurses noticed that this pump was more ¿loose¿ than previous pumps.The patient was still on the same pump, but equipment had been changed when this happened previously.Related manufacturer reference number: 3003306248-2024-00002, 3003306248-2024-00001.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the reported event of the speed and flow falling to 0 was confirmed via log file analysis.A log file was extracted from centrimag console (b)(6).A review of the log file contained data spanning between (b)(6) 2022 - (b)(6) 2024, per timestamps.Between (b)(6) 2023 at 20:37:24 and (b)(6) 2023 at 14:20:12, intermittent ¿flow signal interrupted: f2¿ and ¿flow below minimum: f3¿ alarms activated due to the flow briefly falling to 0 liters per minute (lpm).The alarms and flow quickly resolved each time.On (b)(6) 2023 between 22:18:18 ¿ 22:18:28, 22:19:18 ¿ 22:19:28, and 22:20:12 ¿ 22:20:29, ¿sf_lmc_shutdown_initiated¿ and ¿sf_lmc_main_mode_disabled¿ faults and ¿set pump speed not reached: m5¿ and ¿flow below minimum: f3¿ alarms were active due to the motor speed and flow falling to 0 rotations per minute (rpm) and 0 lpm, respectively.The flow and motor speed resumed shortly after each event.On (b)(6) 2023 at 15:20:30, the set sped was decreased to 650 rpm.Quickly after the speed change, a ¿sf_lmc_pump_not_detected¿ fault and ¿pump not inserted: m3¿ alarm activated.The system was then shutdown at 15:22:16.The console was power cycled several times until it was returned to the service depot.The centrimag 2nd generation primary console (s/n: (b)(6)) was evaluated at the service depot.No physical anomalies were observed.The console was connected to the returned motor and a test loop.The system was run for several days and operated as intended.During the extended operation, the motor's cable was flexed throughout its entire length and no alarms activated.The motor and console underwent functional testing and passed without issue.The motor and console were returned to the customer site.Per the provided information, the no flow and pump stop resolved without any intervention.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 console (s/n: (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 13 entitled ¿console alarms and alerts¿ addresses how to properly interpret and troubleshoot all system alarms, including motor and flow alarms.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 CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18465229
• MDR Text Key: 332415390
• Report Number: 2916596-2024-00137
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/20/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 201-90411
• Device Lot Number: 8570067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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
• Patient Age: 6 MO
• Patient Sex: Male
• Patient Weight: 5 KG