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

Model Number 201-90411

Device Problems Electrical Power Problem (2925); Infusion or Flow Problem (2964); Insufficient Information (3190)

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

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

Due to system limitation the following was added to h10 of mdr: section h6: health effect - clinical code e2343 hemodynamic instability no additional information has been provided.The manufacturer is closing the file on this event.

Event Description

Related manufacturer report number: 3003306248-2023-05067.It was reported that the centrimag motor dropped to zero rpm and had a red alarm.The device was exchanged 15 minutes following the start of the alarms.At the time of the event, the patient's blood pressure dopped and their blood oxygen levels went down.These parameters normalized once the patient was on the backup equipment.

Manufacturer Narrative

Manufacturer's investigation conclusion: incidental findings: use of expired product, s3 alarm the reported event of the motor speed dropping to 0 rpm on (b)(6) 2023 was confirmed via the log file.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 8 days ((b)(6) 2023, (b)(6) 2023, per time stamp).On (b)(6) 2023, the console was operating at a speed of ~3700 rpm with a flow of ~3.7 lpm.At 18:53, a ¿flow below minimum: f3¿ alarm and a ¿motor disconnected: m2¿ alarm activated, and the flow dropped to a negative value and the motor speed dropped to 0 rpm.The motor speed and flow resumed within the same minute.The console was shutdown at 19:13.The console was returned for analysis to the service depot and the reported event was unable to be reproduced.The console was connected to the returned motor and a mock loop and run for several days with no alarms or interruption of support.The motor cable was manipulated during testing and operated as intended.The console was tested independently and operated as intended.The console was functionally tested and passed all tests.Additional provided information communicated on (b)(6) 2023 by (b)(6) stated that they switched to the backup system within 15 minutes of the event.There was no long-lasting harm.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 (serial #: (b)(6)) and the console was found to pass all manufacturing and qa specifications.The console battery (serial #: (b)(6)) was originally shipped with the console.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 13 entitled ¿console alarms and alerts¿ addresses how to properly interpret and troubleshoot all system alarms including s3, m2, f2, and f3 alarms.The 2nd generation centrimag system operating manual table 15 entitled ¿console maintenance schedule¿ addresses the proper maintenance schedule for the centrimag system which details to replace the internal battery every 2 years.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

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: 17685746
• MDR Text Key: 322669972
• Report Number: 3003306248-2023-05068
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2024

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: 201-90411
• Device Lot Number: 7998688
• 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: 08/30/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 11/20/2023; 01/24/2024
• Supplement Dates FDA Received: 11/28/2023; 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 95 KG