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

Model Number 201-90411

Device Problem Data Problem (3196)

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

Event Date 12/25/2021

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient, who has a history of balock-taussig shunt (bts), atrial septostomy, and pedimag implant on (b)(6) 2021 had difficulty with their data logger.The data logger has not been showing events past (b)(6) 2021.The system has alarmed and parameters changed multiple times since (b)(6) 2021.The patient has been on the same primary system since implant, the console has not been turned on or off, and the monitor has not been disconnected or reconnected to the console.The data logger has been accessed and there have been no alarms or events displayed beyond (b)(6) 2021.The clinical consultant went to the account and it was evident that live pump parameters were visible; however, they were unable to download history past (b)(6) 2021.

Event Description

Additional provided information communicated that it was unknown if the issue was related to the console or the monitor.The monitor was unplugged/plugged in and monitor was then able to download data past on (b)(6) 2021.

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 a log file recording issue was confirmed via review of the log file.The centrimag 2nd generation primary console (serial #: (b)(6)) was not returned for analysis; however, a log file was submitted for review with events spanning 5 days ((b)(6) 2021 ¿ (b)(6) 2021, (b)(6) 2022- (b)(6) 2022 per time stamp).The log file confirmed that data was not recorded between (b)(6) 2021 at 17:38:31 to (b)(6) 2022 at 13:59:40.There were no notable events active in the log file.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 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 section 7.22 entitled "the systeem data logger" states that the system data logger allows users to view a log of significant events that have occurred since the system was powered up.Table 9 entitled "event types for the system data logger" addresses which siginifcant events are logged and how they appear.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: 13260431
• MDR Text Key: 287279343
• Report Number: 3003306248-2022-00001
• 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: 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: 03/16/2022

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: 08/31/2021
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 7141688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 03/15/2022
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2019
• 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
• Patient Age: 2 MO
• Patient Sex: Female
• Patient Weight: 4 KG