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

Model Number L201-90411

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 08/27/2021

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 patient was on ecmo (extracorporeal membrane oxygenation) support via centrimag with a euroset oxygnator.There was a no flow alarm and s3 alarm noted on the monitor on (b)(6) 2021.The centrimag console screen was blank, the pump was running (turbulence visualized and motor was heard audibly).It was attempted to silence the alarm but it persisted.Per centrimag recommendations for an s3 alarm, the patient was switched to backup centrimag motor and console.The patient tolerated the console/ motor change.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a s3 alarm was confirmed via the log file.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis and a log file was downloaded for review with events spanning approximately 4 days ((b)(6) 2021 per time stamp).Events occurring on (b)(6) 2021 took place during lab testing at abbott.The console was operating a motor at a speed of ~5100 rpm with a flow of ~5.4 lpm.On 27aug2021 at 03:49:26, an ¿sf_ifd_shutdown_detected¿ sub fault activated, triggering a ¿system alert: s3¿.The motor speed dropped to ~3100 rom and the flow dropped to 0 lpm at 03:49:29.A ¿set pump speed not reached: m5¿ alarm activated at 03:49:32 and was followed by a ¿motor alarm: m4¿ at 03:49:41.These alarms were able to be muted.At 03:50:03, a ¿flow signal interrupted: f2¿ alarm activated.This alarm was able to be muted and cleared but continued to activate.The pump was stopped due to user request at 03:52:17.The system was shut down at 03:55:01 and was power cycled.The alarms were no longer active.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was returned for analysis and the reported event was not able to be duplicated or verified.The console was connected to a test loop and was run for several days with no alarms observed.A full functional test was performed, and all tests were passed.The console was previously tested with the retuned and associated motor and flow probe and the functioned as intended.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 2nd generation primary console (serial #: (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 & alerts¿ details the various alarms and alerts and the appropriate operator response, including s3 alarms.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Related manufacturer reference number: 3003306248-2021-04038.

• 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: 12528096
• MDR Text Key: 273759152
• Report Number: 3003306248-2021-04037
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: L201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 5873032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 01/28/2022
• Supplement Dates FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2017
• 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 Outcome(s): Other
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 131 KG
• Patient Ethnicity: Hispanic
• Patient Race: White