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

Model Number 201-90401

Device Problems Failure to Power Up (1476); Unexpected Shutdown (4019)

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

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that in the intensive care unit (icu) the centrimag stopped and could not be started.No alarms were noted but the console and motor had to be changed.

Manufacturer Narrative

Reporter email and phone number were not available.Manufacturer's investigation conclusion: the reported event of the centrimag system stopping and not being able to restart was confirmed via analysis of the submitted log file and testing of the returned unit.The centrimag console (serial number (b)(6) was returned and evaluated at the european distribution center (edc) and a log file was downloaded.The downloaded log file contained events spanning approximately 6 days (07sep2023, 08sep2023, 14sep2023, 15sep2023, 27sep2023, 05dec2023, per the timestamp).Data captured on 05dec2023 is consistent with data captured while the console was returned to the edc.The console was operating at approximately 3800 revolutions per minute (rpm) with a flow of approximately 4 liters per minute (lpm); however, when the console was experiencing the intermittent atypical shutdowns, the speed and flow dropped below the minimum thresholds.On 08sep2023 at 2:44:48, an atypical shutdown of the console was observed; however, the console does not appear to be powered off.Several other atypical system shutdowns were active throughout the log file and the root cause is unknown.The log file captured several intermittent console alarms including m2 alarms active due to a sf_lmc_motor_disconnected sub fault, m4 alarms due to a sf_lmc_levitation sub fault, s3 alarms due to a sf_lmc_local_iic sub fault, an s3 alarm active due to a sf_flow_supply_15v, and m5 alarms due to a sf_lmc_underspeed sub fault.The alarms, with the exception of the m5 alarm, were muted, cleared and the root cause of the alarms is unknown at this time.During the edc evaluation, the console and motor were run on a mock loop for an extended period of time and m4 and m6 alarms were active.After analysis, the lmcebpx printed circuit board (pcb) was deemed suspect and the unit was forwarded to product performance engineering (ppe) for further analysis.During ppe analysis, the unit was run on a mock circulatory loop for an extended period of time with no issues or atypical alarms active.The reported event could not be reproduced during testing.Provided information stated that exchanging the equipment resolved the issue and the patient remained without centrimag support for approximately 5 minutes.The root cause of the reported event could not be conclusively determined through this analysis; however, the lmcebpx pcb could have contributed to the reported event.Review of the device history record for centrimag 2nd generation primary console (serial number: (b)(6) showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 3 "warnings and 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 11.1-"appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including flow- and pressure-related alarms, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information was received that the patient remained without centrimag support for about 5 minutes and was asymptomatic during the event.No issues with the pump were noted and exchanging the products resolved the issue.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 17954416
• MDR Text Key: 325897666
• Report Number: 3003306248-2023-07162
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

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: Lay User/Patient
• Device Model Number: 201-90401
• Device Lot Number: 5689286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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