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

Model Number 201-90411

Device Problems No Display/Image (1183); Unexpected Shutdown (4019)

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

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Related manufacturer report number 3003306248-2021-02996.It was reported that the pump was in use for extracorporeal membrane oxygenation support and lost flow.It was noted that the pump motor had stopped and the pump and console were changed successfully.There were no adverse consequences to the patient.The original console in use was powered off and the alarm log could not be accessed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the motor stopping, and no flow 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.A review of the downloaded log file showed events spanning approximately 4 days (25jun2021 ¿ 26jun2021, 28jun2021, 08jul2021 per time stamp).The console was operating a motor at a speed of ~4100 rpm with a flow of ~5.1 lpm.On 26jun2021 at 12:55:15, a ¿flow sensor disconnected: f1¿ alarm activated causing the flow to drop to 0 lpm.The motor speed remained at ~4100 rpm before being increased to ~4200 rpm at 12:55:34.The minimum flow was adjusted from 2 lpm to 0 lpm at 12:56:00.The flow continued to remain at 0 lpm.At 12:58:37, a ¿can bus send error¿ due to a ¿st_i2c_com_failed¿ stack trace error was triggered.At the same time, a ¿motor disconnected: m2¿ alarm activated causing the motor speed to drop to 0 rpm.A ¿system alert: s3¿ alarm activated at 12:58:39.All alarms were able to be muted, but not cleared.The console was powered down at 13:01:30.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was returned for analysis and was functionally tested.The reported event was unable to be duplicated or verified.The console was tested with the returned and associated centrimag motor and a mock loop, as well as with test equipment.The console was always able to operate a motor at the set speeds and flow levels with no issues.The console always operated as intended.A full functional checkout was performed, and the unit passed all tests.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 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 alarms.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: 12233164
• MDR Text Key: 268237046
• Report Number: 3003306248-2021-02995
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 111