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

Model Number 201-90411

Device Problems Electrical /Electronic Property Problem (1198); Insufficient Information (3190)

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

Event Date 06/14/2022

Event Type  malfunction  

Event Description

Related manufacturer report number: 3003306248-2022-11289.It was reported that on (b)(6) 2022 around 11:00 am, the centrimag console screen showed a b3 alarm after a self-test was performed.The battery was exchanged in attempt to resolve the alarm; however, after the battery was exchanged an s3 alarm appeared.

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.Initial reporter address: (b)(6).

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a b3 alarm was not confirmed; however, the reported event of a s3 alarm was confirmed.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 14 days ((b)(6) 2022 per time stamp).Events occurring on (b)(6) 2022 took place during testing at abbott.On (b)(6) 2022 at 20:38:00, a ¿system fault: s3¿ alarm activated following ¿sf_sps_power_source¿ sub-fault.The s3 alarm continued to activate intermittently between (b)(6) 2022 at 16:24:00 to (b)(6) 2022 at 13:54.There were no b3 alarms active in the log file.There were no other notable alarms active in the log file.Pump operation was not affected.The centrimag 2nd generation primary console was returned for analysis to the service depot and was evaluated and tested.The console was connected to a test loop and was powered on and a s3 alarm was active on the console, confirming the reported event.The console was further inspected and the sps printed circuit board (sps) was found to be causing the s3 alarm.All other components were in good condition.The customer was provided a repair quote several times and did not provide approval.The console was nor repaired and was sent back to the customer.The root cause for the reported event was conclusively determined to be due an issue with the sps pcb; however, a further root cause 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 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 16 entitled ¿console alarms and alerts¿ addresses how to interpret and troubleshoot all system alarms including s3 and b3 alarms.The 2nd generation centrimag system operating manual table 15 entitled ¿console maintenance schedule¿ states that the battery needs to be replaced every 2 years.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: 14798967
• MDR Text Key: 302795539
• Report Number: 3003306248-2022-11288
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 7640135140702
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

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: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• 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