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

Model Number 201-90411

Device Problem No Audible Alarm (1019)

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

Event Date 03/19/2021

Event Type  malfunction  

Event Description

It was reported that the patient was being transferred to another center when the console was turned off and the pump stopped.Once at the receiving center, the console was plugged in and powered on to restart the motor.The patient was fine and switched to receiving center equipment.The patient was not switched to receiving center equipment in transit as the team did not have a backup console with them at the time.The patient was transferred without complication to the patient.Additional information was requested from the account.There was no alarm when disconnected from good power and no repeating alarm to remind the team that they were on battery.The account transported the patient to an outside hospital.Enroute to the emergency department bay, the pump gave a low power alarm then abruptly shut down.The account plugged the power cord into the ambulance a/c power and resumed ecmo.Upon investigation afterward, batteries were found to be old and out of service.There was confusion between the account's biomedical department and the manufacturer over who was performing the pm service.Batteries were replaced by the account's biomedical service and an inhouse biannual service plan was initiated.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag console (serial number: (b)(6)) suddenly shutting down was not confirmed as no log files were submitted for review and no products were returned for evaluation.Additional information communicated that while the patient was being transported to a different hospital, a low battery alarm activated; this alarm is consistent with prolonged use of the console when it is being supported solely by the internal battery.After the alarm activated, the system then suddenly shut down.Once the console was reconnected to ac power, the system booted up and fully functioned as intended.It was stated that upon further inspection, the console¿s internal battery was observed to be expired and out of service.An expired or out of service internal battery may not be able to support the console for a prolonged period of time, which could have resulted in the reported event of the system suddenly shutting down.It was also communicated that the battery was discarded, and that the battery and console would not be returned for evaluation.The root cause of the reported event appears to be due to the use of an expired battery.The device history records were reviewed and the records revealed that the centrimag console, serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 10 ¿ ¿emergencies/troubleshooting¿ provides instructions for operation when there is a need to exchange the main console or motor with a backup console or motor.The recommended practice whenever there is a 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 back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.The 2nd generation centrimag system operating manual section 4 ¿ "warnings & precautions" states that 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 pedimag 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 9 ¿ ¿maintenance¿ instructs users to perform battery maintenance on centrimag console¿s internal battery every six months.Users are also instructed to replace the console¿s internal battery every two years.The document also explains that the user may not replace the internal battery without proper training by abbott medical or its distributor.Users are instructed to call abbott medical customer service if the internal battery requires replacement.The 2nd generation centrimag system operating manual section 12.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), including battery alarms, and the appropriate actions to take if the issue does not resolve.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
• MDR Report Key: 11648152
• MDR Text Key: 268235561
• Report Number: 3003306248-2021-01096
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 81