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

Model Number 201-90411

Device Problems Decreased Pump Speed (1500); No Apparent Adverse Event (3189)

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the centrimag motor would not maintain the correct speed after being on support since (b)(6) 2021.Both the centrimag console and motor were exchanged.Related manufacturer's reference # for the motor: 3003306248-2021-05727.

Manufacturer Narrative

Section d4: expiration date inadvertently reported in initial report and is not applicable for this device manufacturer's investigation conclusion: the reported event of the system not maintaining the set speed was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6)) and a log file was downloaded for review.A review of the downloaded log file showed events spanning approximately 4 days ( (b)(6) 2021, (b)(6) 2022 per time stamp).Events occurring on (b)(6) 2022 took place during lab testing at abbott.The motor appeared to have not been connected throughout the entire log file.The centrimag 2nd generation primary console was returned for analysis to the service depot and the reported event was unable to be duplicated.The console was connected to a test loop and run for several days with no alarms observed.A full functional test was performed, and the unit passed all tests.The console was also tested with the returned and associated moto and operated 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 (b)(6) and 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.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: 13009668
• MDR Text Key: 282608021
• Report Number: 3003306248-2021-07025
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 7640135140702
• 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: 02/07/2022

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: 07/31/2022
• Device Model Number: 201-90411
• Device Lot Number: 7598329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 02/04/2022
• Supplement Dates FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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: 24 YR
• Patient Sex: Female
• Patient Weight: 83 KG