MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102956

Device Problem Insufficient Information (3190)

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

Event Date 10/13/2022

Event Type  malfunction  

Event Description

It was reported that the patient was on extracorporeal membrane oxygenation (ecmo) while in the operating room.Just before transfer to the intensive therapy unit (itu), the cart was unplugged from the mains.There was an immediate s3 error on the console which could not be cleared.There was no issue or change in flow, but it was decided to swap to a new console, motor, and flow probe.Related manufacturer's report number for the console: 3003306248-2022-14523.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: incidental findings: motor cable connector cap damaged the reported event of a s3 alarm was confirmed.The centrimag motor (serial #: (b)(6)) was returned for analysis and a log file was downloaded from the returned and associated centrimag 2nd generation primary console for review.A review of the downloaded log file showed events spanning approximately 12 days (19sep2022 ¿ 20sep2022, 25sep2022, 30sep2022 ¿ 01oct2022, 04oct2022 ¿ 07oct2022, 12oct2022 ¿ 13oct2022, 09mar2023per time stamp).Events occurring on 09mar2023 took place during testing at abbott.Beginning on (b)(6) 2022 at 20:50 a sub-fault ¿sf_lmc_motor_iic¿ activated and triggered a ¿system alert: s3¿ alarm.Pump operation was not interrupted.This alarm was able to be muted and cleared but continued to reactivate.The console was powered off on (b)(6) 2022 at 21:45.There were no other notable events active in the log file.The centrimag motor was returned for analysis to the european distribution center (edc).During functional testing, the reported s3 alarm was able to be reproduced after a short time.The motor was forwarded to product performance engineering (ppe) for further analysis.Upon analysis with ppe, the motor was connected to a calibrated test centrimag system and upon turning the system on, a ¿system alert: s3¿ alarm was active.The motor speed was able to be adjusted and operate while the alarm was active.The motor cable was manipulated, and the alarm remained active.Motor operation was not interrupted.The motor cable then underwent resistance testing.An open lead was found on the i2c-scl/i2c-sda line.When the motor cable was manipulated near the lemo connector end, the value fluctuated.The motor cable lemo connector was opened and the i2c-scl wire (pink wire, position four) was found to not be properly soldered to the lemo connector.The root cause for the reported event was conclusively determined to be due to an improper solder connection at the motor lemo connector.A previous manufacturing task investigated this issue and resulted in opening a non-issuance scar to inform the supplier.This motor was manufactured prior to the initiation of the scar.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." the 2nd generation centrimag system operating manual table 13 entitled ¿console alarms & alerts¿ states how to properly interpret and troubleshoot all system alarms including s3 alarms.The 2nd generation centrimag system operating manual table 15 entitled ¿console maintenance schedule¿ states to replace the battery every 2 years.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: 16017835
• MDR Text Key: 308352841
• Report Number: 3003306248-2022-14524
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2020
• 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