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

Model Number 201-90401

Device Problems Electrical Power Problem (2925); Unintended Electrical Shock (4018)

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

Event Date 07/05/2022

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the centrimag flow probe failed the electrical safety test (protective earth resistance test) and tested to be more than 0.2 ohm.The change of the power cable did not reduce the resistance.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the console not passing the electrical safety test was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6) was returned for analysis to the european distribution center (edc) and was evaluated and tested.A current leakage test was performed multiple times which always resulted in values lower than 0.20o.A full functional test was performed, and the unit was found to function as intended.He reported event was unable to be reproduced.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 motor (serial #: (b)(6) and the motor 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.

Event Description

Correction: it was reported that the centrimag console failed the electrical safety test (protective earth resistance test), tested to be more than 0.2 ohm.The change of power cable did not reduce the resistance.

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

• 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 CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15139115
• MDR Text Key: 304826699
• Report Number: 3003306248-2022-11569
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2022

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 Model Number: 201-90401
• Device Lot Number: 6335627
• 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: 07/06/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 09/15/2022; 11/08/2022
• Supplement Dates FDA Received: 09/19/2022; 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2018
• 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