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

Model Number L201-90411

Device Problems Display or Visual Feedback Problem (1184); Infusion or Flow Problem (2964); Insufficient Information (3190)

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

Event Date 06/03/2022

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 the centrimag monitor alarmed with an m4 alarm - pump not recognized and a no flow alarm on (b)(6) 2022.The centrimag console was completely black at this time.The patient was still receiving flow from the centrimag pump.The equipment was switched to the backups and the console was removed from service.There were no further issues after exchanging the console.The patient remained on centrimag support.Motor mfr # 3003306248-2022-11567.

Manufacturer Narrative

Section d4: expiration date inadvertently provided in previous report.Expiration date is not applicable for centrimag 2nd generation primary console.Manufacturer's investigation conclusion: the reported events of the centrimag console¿s screen becoming blank and alarms correlating to motor and flow issues were both confirmed via a provided image and via the log file extracted from the centrimag console during testing respectively; however, it was determined that the console was unrelated to the cause of the events.The returned centrimag console (serial number (b)(6)) was received at the service depot.The console was functionally tested for an extended period and was found to perform as intended.The console¿s housing was opened and inspected, and all cabling and components appeared unremarkable.The console operated a mock loop as intended for several days, then the console was returned to the rental pool after passing all tests per procedure.A log file was extracted from the console during testing.On the reported event date, 03jun2022, the system was operating at ~4400 rpm / 4.5 lpm.At 00:47, an s3 alarm correlating to an ifd_shutdown sub-fault was observed.Due to this event, the pump speed fell to ~3000 rpm and was unable to be set to higher speeds, and the flow value became blank.An m4: motor alarm and an m5: set speed not reached alarm both became active as well.The set speed was observed to have been changed a few times; however, the speed kept dropping to ~3000 rpm due to the fault.The system was observed to have been manually shut down on 03jun2022 at 1:51 and was not observed to have been in patient use throughout the remainder of the data.The s3, m4, and m5 alarms in addition to the flow blanking, speed dropping, and the console¿s screen becoming blank, all correlating to the atypical ifd_shutdown event, were determined to be an issue with the centrimag motor (serial number l02254-0012, evaluated separately), as these events occurring in tandem is a known motor failure mode.This issue has been addressed via the motor¿s investigation (mfr # 3003306248-2022-11567), and no further issues regarding the console were reported nor observed.Review of the device history record for centrimag 2nd gen.Primary console, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual (rev.M) provides information regarding emergencies/troubleshooting in section 10.The recommended practice whenever there is a 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 back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of the centrimag console¿s screen becoming blank and alarms correlating to motor and flow conditions were both confirmed via a provided image and via the log file extracted from the centrimag console during testing respectively.Per the log file, on the reported event date of 03jun2022, the system was operating at ~4400 rpm / 4.5 lpm.At 00:47, an s3 alarm correlating to an ifd_shutdown sub-fault was observed.Due to this event, the pump speed fell to ~3000 rpm and was unable to be set to higher speeds, and the flow value became blank.An m4: motor alarm, an m5: set speed not reached alarm, and an f2: flow signal interrupted alarm were also observed within this timeframe due to the sub-fault.The set speed was observed to have been changed a few times; however, the speed kept dropping to ~3000 rpm due to the sub-fault.The system was observed to have been manually shut down on 03jun2022 at 1:51 and was not observed to have been in patient use throughout the remainder of the data.The reported blanking of the console¿s screen would have also occurred due to the observed ifd_shutdown sub-fault.The returned centrimag console (serial number (b)(6)) was received at the service depot.The console was functionally tested for an extended period and was found to perform as intended.The console¿s housing was opened and inspected, and all cabling and components appeared unremarkable.The console operated a mock loop as intended for several days, then the console was returned to the rental pool after passing all tests per procedure.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for centrimag 2nd gen.Primary console, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual (rev.M) provides information regarding emergencies/troubleshooting in section 10.The recommended practice whenever there is a 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 back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.The 2nd generation centrimag system operating manual (rev.M) section 12.1 entitled "appendix i-2nd generation centrimag primary console alarms and alerts" contains a list of console alarms and alerts, including system, motor, and flow alarms, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE RENT
• 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: 14842100
• MDR Text Key: 303090891
• Report Number: 3003306248-2022-11566
• 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: K020271
• 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,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: L201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 5687176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2013
• 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
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 95 KG