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

Model Number 201-30300

Device Problems Electrical /Electronic Property Problem (1198); Pumping Stopped (1503)

Patient Problem Cardiac Arrest (1762)

Event Date 05/23/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the primary and backup console had b2 alarms.The consoles could not maintain power on battery for 15 minutes although the screen battery time reported over 2 hours.This was discovered during transport of the patient.The patient was noted to have required cpr for less than 5 minutes until the unit was connected to ac power again.A debried was done with the account.It was discovered that the battery had been expired since 2016.The preventative maintenance was not performed according to the ifu.The battery maintenance has not been documented since the console was bought nor were the batteries changed.The preventative maintenance was not performed by an authorized representative, but done by hospital staffed biomedical engineers.The patient survived and was noted to be stable in the pediatric intensive care unit (picu).It was noted that the battery preventive maintenance was performed in january of 2021.No additional information was provided.

Event Description

Related manufacturer report number: 3003306248-2021-02973.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a b2 alarm and the battery not maintaining power was confirmed.The centrimag 2nd generation primary console (serial #: l03704-0004) was returned for analysis and a log file was downloaded for review.A review of the downloaded log file showed events spanning approximately 8 days ((b)(6) 2021 ¿ (b)(6) 2021, (b)(6) 2021 ¿ (b)(6) 2021, (b)(6) 2021, (b)(6) 2021 ¿ (b)(6) 2021, (b)(6) 2021 per time stamp).Events occurring on (b)(6) 2021 took place during lab testing at abbott.On (b)(6) 2021 at 12:22, ¿battery below minimum: b2¿ and ¿low battery: b5¿ alarms were active.These alarms were able to be muted and cleared.The console was powered down.Pump operation was not affected.There were no other notable alarms related to the reported event active in the log file.The centrimag 2nd generation primary console was returned for analysis and the reported event was able to be reproduced.The console was powered on while connected to a test loop and upon power up, the console displayed a b4 alarm.The battery was noted to have expired on (b)(6) 2016 and would not pass battery maintenance.The battery was replaced.And a successful battery maintenance was performed.The unit ran as intended for several days with no active alarms.The unit passed all tests and the replaced battery was forwarded to product performance engineering.Upon further inspection with ppe, the battery was confirmed to have expired on (b)(6) 2016 but was otherwise in unremarkable condition.Additional provided information communicated on (b)(6) 2021 stated that the system as switched to the backup console but the b2 alarm also occurred on the backup console.It was noted that the battery was expired since 2016 and preventative maintenance was not done according to the instructions for use (ifu).Additional provided information communicated on (b)(6) 2021 stated that the engineers did not follow ifu instructions for battery maintenance.Battery maintenance had not been documented being done since the console was purchased.The batteries were never changed.The preventative maintenance was performed by non-thoratec authorized representatives.The root cause of the reported event was conclusively determined to be due to battery maintenance not being followed by the user per the ifu.The device history records were reviewed for the centrimag 2nd generation primary console and the console was found to pass all manufacturing and quality assurance specifications.The battery (serial #: 1400) 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 section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events, including s3, b2, b4, and b5 alarms.The 2nd generation centrimag system operating manual section 7.4 entitled ¿battery maintenance¿ outlines the steps to follow to perform a successful battery maintenance.The 2nd generation centrimag system operating manual table 21 entitled ¿2nd generation primary console maintenance schedule¿ outlines the maintenance schedule for the console including how often battery maintenance should be performed and how often the battery should be replaced.It states that ¿the services listed in table 21 are to be performed by qualified personnel trained by thoratec¿.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.

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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 11937924
• MDR Text Key: 254324443
• Report Number: 3003306248-2021-02974
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2014
• 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 Outcome(s): Life Threatening; Hospitalization; Required Intervention