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

Model Number 201-30300

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the console was requested, information not provided.No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the centrimag console battery did not pass the preventative maintenance test after two attempts.The battey was still within its expiration date and was still functional and working under correct parameters and environment.The battery was exchanged and test to be performed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag console battery not passing the preventative maintenance test after two attempts was not confirmed.The centrimag console (serial number (b)(6)) was not returned for analysis.Additionally, there were no log files, photos, or any other supporting documents submitted that would confirm the reported event.It was further reported that the battery was installed in (b)(6) 2022, and the expiration date was in 2025; therefore, the battery was not expired at the time of the event.Provided information stated that the serial number of the console is (b)(6), the serial number of the battery is (b)(6), and the battery is not returning.The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed for the centrimag 2nd generation primary console (serial number: (b)(6)) and the console was found to pass all manufacturing and quality assurance 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 15 entitled ¿console maintenance schedule¿ addresses how often to perform maintenance including when to perform battery maintenance and when to replace the battery.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18367521
• MDR Text Key: 331019950
• Report Number: 3003306248-2023-08403
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

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: Health Professional
• Device Model Number: 201-30300
• Device Catalogue Number: 201-90411
• Device Lot Number: L06525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2019
• 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