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

Model Number 201-90411

Device Problems No Display/Image (1183); Insufficient Information (3190)

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

Event Date 01/08/2023

Event Type  malfunction  

Event Description

It was reported that centrimag started alarming while patient was asleep.The screen displayed m1 red alarm, and console was black with no screen, zero flow.The console was restarted, and the pump was reseated, but could not get the flow, so the patient was switched to a backup.The patient did not code, stable.The patient had been on support since 05:00 and the event occurred on the same day at 1537.The console was set up on cart where everything was plugged into a power strip including backup console and heater/cooler.Nurse reported having issues getting the backup to come on initially.The issue with the backup console was unknown and it did cause a delay in support.Related mfr numbers: motor: 3003306248-2023-00015.Backup console: 3003306248-2023-00016.

Manufacturer Narrative

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

Manufacturer Narrative

Section d4: expiration date incorrectly provided in previous report.Expiration date is not applicable for centrimag 2nd generation primary console.Manufacturer's investigation conclusion: the reported event of the centrimag console displaying a m1 alarm was not confirmed; however, the reported event of the console displaying a blank screen and giving a zero flow reading was confirmed via the downloaded log file; however, it was not reproduced.A log file was downloaded from the returned centrimag console.A review of the downloaded log file showed events spanning approximately 6 days (27nov2022, 30nov2022, 13dec2022, 08jan2023, 09jan2023 and 19jan2023 per time stamp).The system was powered on at 04:09:46 on (b)(6) 2023.The motor was operating at a speed of ~3900 rpm with a flow of ~3.6 lpm.Several pressure alerts were active during the log file, "pressure 1 below minimum: p4¿, "pressure 1 above maximum: p6¿, and "pressure 2 above maximum: p7¿.On (b)(6) 2023 at 16:37 an "sf_ifd_shutdown_detected" occurred indicating that the console screen went black.Following this event, "system alert: s3", "set pump speed not reached: m5", "motor alarm: m4", and "pump not inserted: m3" alarms were active.The speed dropped by ~1000 rpm and the flow blanked to 0 lpm.A "motor disconnected: m2" and "flow signal interrupted: f2" alarms activated as well.Attempts to increase the motor speed were made by the user but were unsuccessful.Two more "sf_ifd_shutdown_detected" events occurred.These alarms seem to clear and reactivate during this event.The console was power cycled at 16:53 and there were no further issues when the console was powered on again.The returned centrimag console, serial: (b)(6), was evaluated at the service depot.The reported issue could not be duplicated.The returned console and motor were connected to a test loop and run for several days.During the investigation period the products were operated at various speeds and flow rates.No alarms or abnormal operation were observed.The returned console was opened and further inspected.The console passed all functional testing.The returned products are ready for use and were returned to the customer.A root cause for the reported event was unable to be conclusively determined.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.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.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 9 "maintenance" states that the battery maintenance procedure needs to be performed every 6 months.If the system requires the battery maintenance procedure to be performed, it will display the alert.Additionally, it mentions to replace the internal rechargeable battery every 2 years.The 2nd generation centrimag system operating manual table 13 entitled ¿console alarms & alerts¿ details the various alarms and alerts and the appropriate operator response, including m1 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 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: 16247930
• MDR Text Key: 309050897
• Report Number: 3003306248-2023-00014
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

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: 11/30/2021
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 7273195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2023
• Initial Date FDA Received: 01/26/2023
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2019
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian